A Blueprint to build strong Foundations for Change.
Professor Carlo DiClemente’s Stages of Change model is feted worldwide for enhancing the understanding and skills which make a substance-abuse treatment provider effective. It helps clinicians develop thoughtful, individually tailored, scientifically grounded treatment plans – here he extends it to policy and programmes.
This article was originally published in Addiction Today journal, March 2005. As we prepare for new – and hopefully more progressive -policies to address addiction treatment, this information is increasingly relevant.
Research tells us that central qualities of the effective clinician are empathy, warmth and positive regard. It also tells us that developing and implementing a clearly articulated treatment plan and providing treatment for the problems a client presents are effective skills. But putting these qualities and skills into action is a challenge.
How does an individual clinician learn to express these central human qualities of caring and compassion with clients who are often difficult and unhappy about being in treatment, and whose central disorder is often characterised by behaviours which do not easily elicit empathy? And given the incredible heterogeneity among substance-use clients, how can a clinician develop a personalised treatment plan grounded in science?
Further, how can we apply those same principles to other workers in the field of substance-use treatment, including members of drug/alcohol action teams? Is there a common framework? Can the process of change be applied at a systemic level as well as at an individual level?
We answered these questions at ARF’s UK/European Symposium on Addictive Disorders in London (where photo on this page was taken). But let’s open up the issue… Deepening our understanding of addiction can also deepen our understanding of the implications for policy and programmes. It can let us see that we need a common framework – such as Models of Care – and a common assessment tool, which has eluded drug/alcohol action teams, to their increasingly vocal frustration. Deep understanding of what our clients are all about, and the meaning of what we are doing, can lead us to a conceptualisation of the entire process of change and the entire continuum of care.

WHAT IS THE STAGES OF CHANGE MODEL?

Developing genuine understanding of – even empathy for – a client requires professionals to look beyond that client’s behaviour when using alcohol or drugs, and to understand the nature of substance-use disorders and difficulties inherent in changing long-standing, pervasive patterns of thought and behaviour. They are helped in this by the ‘stages of change’ model, combined with a good treatment plan.

The current model posits five stages of change:
o precontemplation
o contemplation
o preparation
o action and
o maintenance.

People in the first stage show no sign of intent to change a problem behaviour, be it because of a lack of awareness, unwillingness or a lack of hope because previous attempts failed. Contemplators are more visibly distressed about their problem behaviours than precontemplators and have begun to weigh the positives and negatives of change.
The preparation stage covers people who are ready to change both attitude and behaviour, and to change soon. When people are in the action stage, behaviour change has clearly begun. So they need skills to implement specific change methods. They also need to be aware of the psychological – cognitive, behavioural and emotional – events which can work against their best efforts. And they need to learn how to prevent major reversals, such as having a relapse and returning to pre-change patterns. The action stage lasts an average of about six months.
The last major stage of change is maintenance, where people sustain and strengthen improvements they have made. They can take a few years to eel “secure”.
_____________________________________________
“The stages of change are a model of ‘how to think’
rather than ‘how to do’…
They describe attitudes, intentions and behaviours
related to tasks of change”
_____________________________________________
All of this is voluntary rather than coerced change. Indeed, the stages of change are a model of “how to think” rather than “how to do”. They describe attitudes, intentions and behaviours related to the tasks of change. Note that the “change” sought is specific: commitment to change one behaviour might say nothing about commitment to change a related behaviour. And each stage refers to a time period and to tasks which a person or organisation must complete before moving to the next stage.

COMMON CHARACTERISTICS

Let’s look at the commonalities of clients in the five stages of change – then readers can draw their own conclusions as to the similarities at a systemic level for change in our field.
The common characteristics of people in the precontemplative stage are: defensive, resistant to suggestion of problems associated with their use/ behaviour, uncommitted or passive in treatment/work, consciously or unconsciously avoiding steps to change their behaviour, lacking awareness of a problem, often pressured by others to change, feeling coerced and ‘put upon’ by significant others.
The characteristics of contemplators of change are: seeking to evaluate and understand their actions, distressed, desirous of exerting control or mastery, thinking about making change, have not begun taking action and are not yet prepared to do so, many previous attempts to change, evaluating pros and cons of their behaviour and of changing it.
Now we come to the preparation stage, where people: intend to change their behaviour, are ready to change attitude and behaviour, are on the verge of taking action, are engaged in the change process, are prepared to make firm commitments to follow through on the action option they choose, and are making or have made the decision to change.
Common characteristics of people in the action stage are that they have: decided to change, verbalised or otherwise shown a firm commitment to change, tried to modify behaviour and/or environment, demonstrated motivation, and are willing to follow suggested strategies and activities for change.
And what do we share at the maintenance stage? Characteristics are: working to sustain changes achieved to date, focusing considerable attention on avoiding slips or relapses, feeling fear or anxiety about relapse and facing high-risk situations, and less frequent but often intense temptations to return to old habits.

MOTIVATIONAL STRATEGIES to promote change include giving advice, practising empathy, removing barriers, providing feedback, providing choice, clarifying goals, decreasing desirability of unhealthy habits, and active helping.
CLINICAL STRATEGIES for people in the action stage include maintaining engagement in the change process/treatment, supporting a realistic view of change through small successive steps, acknowledging the difficulties, helping people to identify high-risk situations through a functional analysis and developing coping strategies to overcome these, helping people to find new reinforcers of positive change, and helping people to assess if they have strong support networks.
Clinical strategies for people in the maintenance stage include helping them to identify and sample drug-free sources of satisfaction, supporting lifestyle changes, affirming people’s resolve and self-efficacy, helping them to practise and apply new coping strategies to avoid a return to unhealthy habits, and maintaining supportive contact.

TREATMENT/ACTION PLANNING

Based on information gathered during assessment, this is created in collaboration with each person wishing to change and addresses mutually agreed goals. It serves a variety of purposes, including prioritising short- and long-term goals, choosing the optimal interventions for specific goals, identifying barriers to the achievement of goals, and monitoring progress towards goals over time.
For our new purposes, goals can be as much on a national or local level as they can be on a personal level. They can include decrease in or cessation of substance use, which can impact on other goals such as improving family and employment situations, extending social support networks, and returning to school or college. One obvious benefit of prioritising goals is that attention is focused on the most pressing problems.
Another is that successes in these main areas often place people in a better position to address secondary goals.
It is important to recognise the treatment/action plan as flexible and changeable. Unexpected needs or problems can arise. Some goals might depend on others. Some might take longer than anticipated.

Common features of treatment plans include:
o developed as a result of a comprehensive assessment and modified over time as warranted
o reflects participation from appropriate disciplines – medicine, psychiatry, psychology, social work or vocational rehabilitation – as warranted
o reflects the person’s presenting needs and specifies their strengths and limitations
o consists of specific goals which pertain to the attainment, maintenance and/or re-establishment of physical and emotional health
o identifies specific objectives which relate directly to the treatment/change goals
o specifies the frequency of treatment/change contacts
o includes provisions for periodic re-evaluations and revisions, as needed, of the plan, and
o identifies criteria for determining if goals have been achieved, as well as for terminating change.
Some qualities of well-formed treatment/change goals are that they are: salient and meaningful to the person or organisation wishing change, incremental and so more manageable, concrete, specific and behaviour focused, able to increase desired behaviours, realistic and achievable, seen as requiring work and effort, and are appropriate for the projected change period.

FUTURE DIRECTIONS
In addition to its popularity with many addiction counsellors and researchers, the stages of change model should prove useful in tracking and predicting change. Most people have followed problematic paths over many years and made multiple attempts to change before being successful. They get stuck at certain points in the process of change and invest more time and energy in not changing than in activities to promote change. There is an ebb and flow, and important, distinct tasks which mark the process.
People can move forward and backward through the stages, and they can do so quickly. Their tasks involve a number of dimensions – motivation, decision making, efficacy, coping activities – which have an ongoing influence on the change process, can be accomplished quickly or slowly, and can be done more or less completely. These stages of change seem to resemble the stage dimensions of personality development proposed by Erickson in 1963.
Moving through change does not appear to be a case of doing more of the same thing, but instead doing the right thing at the right time.

There is also a growing body of literature which appears to support the relationship of stages to important outcomes.
One advantages of model is that the process of change is assumed to be the same for substance-abuse problems as well as other life problems.

It has been applied to changes related to many behaviours, including anxiety, medication compliance and health protection. The stages cover considerable ground, since the process of intentional behaviour change is central in the life of an individual, with major implications for growth and development.
There are few models which can be applied to such a variety of behaviours with such consistent results… Let’s change together.

Source: Addiction Today Aug.1st 2010

Ryan Vandrey1 and Margaret Haney2
1 Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
2 New York State Psychiatric Institute and College of Physicians and Surgeons of Columbia University,
New York, New York, USA

Abstract

Cannabis is the most widely used illicit drug in the world. Treatment admissions for cannabis use disorders have risen considerably in recent years, and the identification of medications that can be used to improve treatment outcomes among this population is a priority for researchers and clinicians.
To date, several medications have been investigated for indications of clinically desirable effects among cannabis users (e.g. reduced withdrawal, attenuation of subjective or reinforcing effects, reduced relapse). Medications studied have included those: (i) known to be effective in the treatment of other drug use disorders; (ii) known to alleviate symptoms of cannabis withdrawal (e.g. dysphoric mood, irritability); or (iii) that directly affect endogenous cannabinoid receptor function. Results from controlled laboratory studies and small open-label clinical studies indicate that buspirone, dronabinol, fluoxetine, lithium and lofexidine may have therapeutic benefit for those seeking treatment for cannabis-related problems. However, controlled clinical trials have not been conducted and are needed to both confirm the potential clinical efficacy of these medications and to validate the laboratory models being used to study candidate medications. Although the recent increase in research towards the development of pharmacotherapy for cannabis use disorders has yielded promising leads, well controlled clinical trials are needed to support broad clinical use of these medications to treat cannabis use disorders.

Cannabis (also known as marijuana or hashish) is obtained from the plant Cannabis sativa. Cannabis contains many psychoactive compounds that affect the endogenous cannabinoid receptor system, of which D-9-tetrahydrocannabinol (THC) has been identified as the compound primarily responsible for the subjective ‘high’ experienced by users.[1] The acute effects of cannabis include subjective feelings of euphoria, relaxation, dream-like state, altered sensory perception, slowing of time, anxiety/paranoia and increased appetite. Cannabis also increases heart rate and, in rare instances, can induce hallucinations or psychosis.

THC is a partial agonist of the cannabinoid receptor type 1 (CB1), a G protein-coupled receptor that is expressed in the brain at highest concentrations in the basal ganglia (motor control), cerebellum (sensorimotor coordination), hippocampus (memory) and cortex (higher-order cognition). Like most, if not all, addictive drugs, exposure to psychoactive cannabinoids stimulates brain reward areas and can induce appetitive drug-seeking and drug-taking behaviours. Evidence of these effects includes studies in which exposure to cannabis increased dopamine release in the mesolimbic-dopamine reward pathway, enhanced electrical brain stimulation reward, established conditioned place preference and established drug self-administration.
Similarly, abrupt cessation of long-term cannabinoid exposure produces cellular changes in the brain reward pathway (increased corticotrophin releasing factor, decreased dopamine) that have been linked to the dysphoric effects associated with withdrawal from drugs such as alcohol, opioids and cocaine, and are thought to contribute to relapse. Recognizing that cannabis shares neurobiological features associated with dependence on other drugs is important when considering pharmacological treatment of cannabis use disorders.

The rationale for developing pharmacological treatments for cannabis use disorders is clear. There are an estimated 160 million current cannabis users worldwide, and the number of people who meet criteria for cannabis dependence exceeds that for dependence on any other illicit drug. Treatment admissions for cannabis use disorders in many areas have steadily increased in the past decade, including a 2-fold increase in the US and 3-fold increases in Australia and
Europe. Clinical trials have demonstrated that evidence-based psychosocial interventions (e.g.motivational enhancement, contingency management, cognitive-behavioural therapy) result in overall improved clinical outcomes compared with usual care or delayed control conditions. However, as is common with other drugs (e.g. opioids, cocaine, nicotine), adults and adolescents seeking treatment for cannabis-related disorders have great difficulty achieving and sustaining periods of abstinence: the majority relapsing to use following therapeutic interventions.Thus, there exists a clear need for the development and dissemination of interventions that improve clinical outcomes (e.g. reduced use/abstinence, fewer drug-related problems) for the increasing number of those seeking treatment for their cannabis use.

One method of improving clinical outcomes for patients seeking treatment for cannabis use disorders is to identify medications that exhibit clinical benefit and could be added to existing evidence-based psychosocial treatments. There is evidence that a combination of pharmacotherapy and psychosocial therapy can significantly improve substance abuse treatment outcomes relative to psychosocial treatments alone. Pharmacotherapies can aid in the treatment of drug dependence in several ways. One approach is to identify medications that attenuate symptoms of withdrawal. This can be achieved with agonist/substitute medications (e.g. nicotine patch for tobacco dependence, methadone for opioid dependence) or by use of medications known to alleviate specific withdrawal symptoms (e.g. clonidine for sweating, gastrointestinal disturbance and hypertension during opioid withdrawal).

Another approach for pharmacotherapy is the use of medications that attenuate the reinforcing effects of the target drug. One way this can be done is by directly blocking the receptor with an antagonist (e.g. naltrexone for opioid dependence) or partial agonist (e.g. buprenorphine for opioid dependence). A third approach is the use of medications that induce adverse effects when combined with the drug of dependence (e.g. disulfiram induces nausea when combined with alcohol). There are currently no accepted pharmacological treatment interventions for cannabis use disorders. Identification of such medications is an increasing priority among researchers and clinicians working with cannabis users and has been addressed in a number of recent papers. In this manuscript, we review the extant research investigating medications of potential therapeutic efficacy for the treatment of cannabis dependence. Because of space constraints and the clinical focus of this review, preclinical laboratory studies will not be covered but can be found in other reviews. Areas of focus will include human laboratory studies, clinical case reports and small open-label trials, and controlled clinical trials. This paper will complement and extend previous reviews on the topic.

1. Human Laboratory Studies
1.1 Attenuation of Withdrawal Symptoms Research dating back to the 1970s provides clear evidence that a valid and reliable cannabis withdrawal syndrome occurs. Common symptoms of withdrawal in humans include: anger and aggression, anxiety, depressed mood, irritability, restlessness, sleep difficulty and strange dreams, decreased appetite and weight loss. Chills, headaches, physical tension, sweating, stomach pain and general physical discomfort have also been observed during cannabis withdrawal but are less common.Most symptoms begin within the first 24 hours of cessation, peak within the first week and last approximately 1–2 weeks. Because there is evidence that cannabis withdrawal contributes to the high relapse rates among heavy cannabis users,amelioration of cannabis withdrawal symptoms may be an important target for the development of pharmacological treatment interventions for heavy cannabis users. Much of the current research in humans has been conducted by a group of researchers at Columbia University in the US. There, an inpatient human laboratory model was designed to characterize the effects of medications on the consequences of abstinence from cannabis (e.g. withdrawal symptoms). Research volunteers who smoked cannabis multiple times per day and who were not seeking treatment for their cannabis use were enrolled in a series of studies investigating several medications. Participants smoked cannabis (active or placebo) and received oral medication (active or placebo) each day under double-blind conditions. The protocol used a within-subject crossover design so that each participant received each active and placebo combination of cannabis and medication. Further, most of the laboratory studies administered
medication repeatedly each day until steady state levels were attained prior to assessing the effects of cannabis. The effect of receiving placebo versus active medication during the periods of cannabis abstinence (placebo cannabis) was then evaluated. Outcome variables included round the-clock data on mood and physical symptoms, psychomotor task performance, food intake, social behaviour and sleep. Medications investigated in this model to date have been bupropion, divalproex, nefazodone, lofexidine and dronabinol. Bupropion is used clinically as an antidepressant and for smoking cessation, and is thought to exert clinical effects by inhibiting reuptake of noradrenaline (norepinephrine) and dopamine, and possibly by acting as a nicotine receptor antagonist. Divalproex is used clinically as a mood stabilizer as well as to treat epilepsy and migraine headaches. Divalproex dissociates into valproate ions in the gastrointestinal tract and, though uncertain, clinical effects are thought to be mediated by increased GABA levels in the CNS. Nefazodone is an antidepressant and is believed to operate by blocking postsynaptic serotonin 5-HT2A receptors and, to a lesser extent, by inhibiting presynaptic serotonin and noradrenaline reuptake. Lofexidine is used to treat symptoms of opioid withdrawal and acts as an agonist at the a2-adrenergic receptor. Dronabinol is used clinically as an antiemetic and appetite stimulant, and is a partial agonist of CB1 receptors.
In laboratory studies using the methods described previously, administration of bupropion (placebo or 300 mg/day for 17 days)[42] and divalproex (placebo or 1500mg/day for 29 days) during periods of cannabis abstinence significantly worsened mood compared with placebo. Nefazodone (placebo or 450mg/day for 26 days) significantly decreased ratings of anxiety and muscle pain during abstinence but did not alter other essential features of cannabis withdrawal. Lofexidine (2.4mg/day for 8 days) significantly reduced ratings of chills, restlessness and upset stomach, and improved sleep but was associated with increased sedation during the day. Not surprisingly, the medication that has demonstrated the most clinical potential in reducing cannabis withdrawal has been dronabinol. Dronabinol is a synthetic formulation of THC, the primary psychoactive component in cannabis. In that regard, it is similar to using nicotine replacement products to suppress withdrawal during tobacco abstinence. In one study by the Columbia University researchers, dronabinol (10 mg five times daily for 6 days) significantly
decreased ratings of cannabis craving, anxiety, misery, chills and self-reported sleep disturbance,
and reversed the anorexia and weight loss associated with cannabis withdrawal. This attenuation of withdrawal symptoms occurred even though participants in this study were unable to reliably distinguish dronabinol from placebo. In a follow-up study, dronabinol administered at a higher dose and less frequently (20 mg three times daily for 8 days) again decreased ratings of restless and chills, and reversed anorexia but was associated with significant increases in drug effect, drug liking, irritability and latency to sleep compared with placebo. However, in this same study a combination of dronabinol (20 mg three times daily) and lofexidine (mg/day) decreased ratings of restlessness, chills, craving and upset stomach, and improved multiple measures of sleep but also increased sedation during the day and drug effect ratings. The effects of dronabinol (0 mg, 10 mg and 30 mg, three times daily for 15 days) on cannabis withdrawal were also recently reported in an outpatient study of daily cannabis users not seeking treatment. Dronabinol dose dependently decreased withdrawal symptoms during 5-day periods of abstinence while participants were in their home environment. Compared with placebo,
the 10 mg dose reduced participant ratings of aggression, craving, irritability, sleep difficulty and total withdrawal. Though withdrawal was attenuated at the 10 mg dose, it remained significantly elevated compared with a baseline period when participants smoked cannabis as usual. When participants received the 30 mg dose, withdrawal symptom severity was significantly reduced compared with both the placebo and 10 mg conditions and, more importantly, none of the withdrawal symptom ratings differed from the cannabis-as-usual baseline condition, indicating
a maximum therapeutic effect at this dose. Consistent with the initial study described
previously, the 10 mg dose regimen was not associated with increased ratings of intoxication and was not reliably distinguished from placebo. However, the 30 mg dose was distinguished from placebo by all participants and resulted in significantly increased drug effect ratings.

1.2 Attenuation of Subjective and Reinforcing Effects
Laboratory studies have also investigated the ability of medications to reduce the acute effects of smoked cannabis or orally administered THC. In one experiment, pretreatment with the CB1 receptor antagonist rimonabant significantly attenuated the physiological and subjective effects of smoked cannabis administered 2 hours later. Acute administration of rimonabant 90 mg reduced participant ratings of the strength and liking of the smoked cannabis by approximately 40% and reduced cannabis-induced tachycardia by 59%. In a subsequent study, acute administration of rimonabant 90 mg again reduced cannabis-induced tachycardia, but the
attenuation of subjective drug effects was not replicated. In this same study, repeated daily doses of rimonabant (40 mg) administered for 15 consecutive days to a second group of participants reduced cannabis-induced tachycardia following acute cannabis administration on days 8 and 15. The subjective effects of cannabis were also reduced by rimonabant in this group, but that reduction was only significantly different from placebo on day 8 and not on day 15. Thus, rimonabant reduced the effects of smoked cannabis in two studies, but a reduction of subjective
drug effects was not consistently observed. Additional research is needed to investigate the dose effects of this antagonism and whether it translates to clinically meaningful behaviour change (reduced use or relapse prevention). Studies have also investigated whether the m-opioid receptor antagonist naltrexone, which has been shown to decrease cannabinoid self administration in non-humans, can reduce the subjective effects of cannabinoids in humans. In cannabis users, pretreatment with high doses of naltrexone (50–200 mg) failed to attenuate,and in some cases enhanced, the subjective effects of dronabinol and smoked cannabis. By contrast, a lower, more opioid-selective dose of naltrexone (12 mg) decreased the intoxicating
effects of dronabinol 20mg but not 40 mg in a recent study. These findings indicate that the influence of naltrexone on cannabinoid effects may vary as a function of the naltrexone dose, but also that the effect of naltrexone can be overcome with higher doses of cannabis. The effect of dronabinol on the subjective and reinforcing effects of smoked cannabis has also been investigated. Participants received dronabinol 0 mg, 10 mg or 20 mg four times daily for 3 consecutive days. Each day, participants sampled the dose of cannabis cigarette available that day and were then given four choices during the course of that day to smoke the sampled dose of cannabis or receive a voucher worth $US2 that would be added to their study earnings.
Subjective drug effect ratings were obtained following the sample dose of cannabis under each dronabinol dose condition. Dronabinol attenuated the subjective effects of smoked cannabis but did not affect the choice to smoke cannabis (reinforcing effects). Of note, the competing reinforcer, a voucher worth $US2, may not have been sufficiently sensitive to detect changes in cannabis reinforcing efficacy. Also, each dronabinol dose condition only lasted for 3 days, whereas more time may be needed to see an effect of maintenance medication. Thus, more data are needed to determine whether dronabinol disrupts ongoing cannabis use.

The subjective effects of cannabis have also been evaluated in single studies for several other medications. In a small laboratory study, a 0.4mg dose of clonidine (an a2-adrenoreceptor agonist and opioid withdrawal medication) administered 3 hours prior to smoked cannabis reduced cannabisinduced tachycardia but did not reduce subjective effects. Bupropion (300 mg) decreased ratings of the ‘high’ following smoked cannabis, but, as described previously, this dose also exacerbated withdrawal effects during a period of abstinence. In two other laboratory studies described previously, the subjective effects of smoked cannabis were not altered by nefazodone (450 mg) and were increased following administration of divalproex (1500 mg).

1.3 Relapse Prevention
In one recent study, relapse was modelled in non-treatment seekers by structuring laboratory conditions (charging participants $US10 for a single initial puff of cannabis) so that a return to cannabis use was costly. The effects of dronabinol (20 mg three times daily) and lofexidine (2.4 mg/day) were evaluated both when administered alone and when administered together. In this study, neither dronabinol nor lofexidine alone reduced the number of participants who elected
to smoke any amount of cannabis compared with placebo during a 4-day maintenance period, but the combination of the two drugs doubled therate of complete abstinence (25% abstinent for each medication alone, 50% for the combination).Compared with the placebo condition, the average amount of money spent per day on cannabis was reduced in both the lofexidine alone and the combined medication conditions.

2. Case Reports and Small Open-Label Studies

Several studies have investigated the efficacy of potential treatment medications for cannabis dependence in small clinical samples. One recent open-label study investigated atomoxetine as a potential pharmacotherapy in adults presenting for treatment of cannabis dependence. Atomoxetine is a non-stimulant medication that inhibits noradrenaline reuptake and is used to treat attention-deficit hyperactivity disorder. Thirteen participants received atomoxetine (25–80 mg/day; mean 62 mg/day) for 11 weeks. A non-significant reduction in cannabis use was
observed. However, several adverse events were reported, including clinically significant gastrointestinal problems in 77% of participants. Two participants withdrew from the study because of these adverse effects. An open-label investigation was also conducted with the anxiolytic medication buspirone, a 5-HT1A receptor agonist and dopamine D2 receptor mixed agonist/antagonist.[60] Ten treatment-seeking cannabis users received buspirone (up to 60 mg/day; mean 39 mg/day) for up to 12 weeks. Self-reported cannabis use declined from
use on 73% of days prior to treatment to use on 39% of days during treatment, and 44% of urine drug screens conducted during treatment were negative for cannabis (100% positive at intake). Significant decreases in craving and irritability during treatment were also observed. However, several adverse events were reported during the trial and only two participants completed the entire 12-week study. Following a preclinical study showing that lithium, a mood stabilizer that enhances oxytocin expression, attenuated cannabis withdrawal in rats, two small open-label clinical studies were conducted. In one study, lithium was administered to nine adults presenting for treatment of cannabis dependence. All participants indicated that previous quit attempts resulted in significant withdrawal symptoms and that abstinence failed to extend beyond a few days or weeks. Lithium (600–900 mg/day) was administered for 6 days and resulted in reduced withdrawal severity in four of the nine participants. However, cannabis was admittedly smoked during this period by one of these four participants and cannabis abstinence was not verified in the others. In the second study, 20 cannabis-dependent participants received lithium (500 mg twice daily) for 7 days in an inpatient detoxification facility. Twelve participants (60%) completed the 7-day inpatient detoxification (two were removed because of adverse events). Cannabis abstinence at post-treatment follow-up sessions was 64% (day 10), 65% (day 24) and 41% (day 90). Participants also self-reported cannabis abstinence on 88% of days post-treatment, with five participants reporting continuous abstinence that was corroborated with urine toxicology tests on day 90. To date, the only published report in which dronabinol has been used clinically to treat cannabis dependence is a paper describing two case studies. In both cases, the patients used cannabis daily and had repeatedly failed in prior quit attempts. Dronabinol was started at a dosage of 30 mg/day (10 mg three times daily) and then adjusted in both cases. Both patients were able to achieve sustained periods of abstinence; however,adjunct medications were required (divalproex for case 1 and venlafaxine for case 2). In case 1, the patient was successfully tapered off dronabinol without relapse. In case 2, removal of dronabinolresulted in either relapse or heavy alcohol use. This patient continued using dronabinol (5 mg two to three times daily) as a maintenance medication. A case report has also been published in which the atypical antipsychotic medication quetiapine was administered to eight cannabis-dependent patients with a diagnosis of either schizophrenia or bipolar disorder. Following quetiapine administration at a mean dosage of 388 mg/day (range 100–1200 mg/day) for an average of approximately 6 months, cannabis use in these eight patients was reported as being reduced from an average of 35.6 g/week to 1.1 g/week. Concomitant medications administered during the
quetiapine treatment period included unspecified antidepressants (n = 4), gabapentin (n = 2) and methadone (n = 1). It is unclear from the report whether cannabis use rates were verified via objective measures (e.g. urine toxicology) or if the medication was well tolerated by all patients who received it.

3. Clinical Trials

At this time, there is only one published controlled clinical trial in which a medication was tested for efficacy in participants presenting for treatment where cannabis dependence was the primary problem. In this double-blind trial, 25 participants were randomized to receive divalproex (500–2000 mg/day; mean 1673 mg/day) or placebo for 6 weeks and were then crossed over to the opposite medication condition. Participants also received weekly relapse prevention counselling throughout the study. Cannabis use was assessed via self-reporting and quantitative urine testing. An overall reduction of cannabis use was reported, but few urine drug screens were free of cannabis, suggesting that sustained abstinence was not achieved. There was no effect of divalproex compared with placebo on any cannabis use measures. Adverse events related to divalproex were common and resulted in discontinuation for three participants, and toxicology analyses indicated that medication compliance was poor among those receiving active medication. One other controlled clinical trial has been published in which cannabis use was measured following administration of medication, but in this study participants represented a subgroup of participants within a larger trial for the treatment of alcoholism and depression primary to their cannabis dependence. Following a brief inpatient detoxification, participants were randomly assigned to receive fluoxetine 20–40 mg/day (a selective serotonin reuptake inhibitor used to treat depression) or placebo for 12 weeks (n = 11 group). Compared with placebo, those who received fluoxetine reported using less cannabis, using cannabis on fewer days, drinking less alcohol and had a greater decrease in ratings of depression. No objective measures of substance use were obtained to verify the self-reports in this study, and it is unclear whether the decrease in cannabis use was mediated by reductions in alcohol use or depression.

4. Conclusion
Efforts to identify medications that can improve treatment outcomes for cannabis use disorders have increased considerably in recent years but still lag far behind the medication development efforts for treating dependence on other drugs (e.g. alcohol, cocaine, opioids). Most of the current research is limited to laboratory models and small open-label trials, with only one published controlled clinical trial (compared with dozens to hundreds of controlled pharmacotherapy trials for treating dependence on alcohol, cocaine, nicotine and opioids). The laboratory studies described in section 1 all employed cannabis users who were not trying to reduce or quit their cannabis use. Although it is possible that this limits the generality of these studies, it is important to point out that for drugs such as cocaine and heroin, the validity of human laboratory studies of self-administration for predicting
medication efficacy in the clinic is better than most other models, including open-label clinical studies, which are often characterized by a high number of false positives. That said, controlled clinical trials for cannabis dependence are clearly needed, not only to determine the efficacy of candidate medications but also to evaluate the predictive validity of the laboratory models being used. At this point, several medications that were studied appear to warrant further investigation
(table I). Dronabinol has been the most extensively studied and appears to be the strongest candidate medication to date. Studies have indicated several clinically important effects of dronabinol (reduction of withdrawal and decreased relapse when combined with lofexidine, and possibly divalproex or venlafaxine). Moreover, agonist medications have demonstrated
efficacy in the treatment of tobacco and opioid dependence. Replication in controlled clinical trials is needed (two placebo-controlled trials are currently being conducted in patients specifically seeking treatment for their cannabis use). Dronabinol has a slow rate of onset and low rates of abuse. However, the safety and abuse liability/ diversion of dronabinol in addiction treatment settings needs to be assessed because the population seeking treatment for cannabis dependence (many adolescents, people with extensive drug use histories and a preference for cannabinoid self-administration) may present with unique safety and abuse liability concerns.
The cannabinoid receptor antagonist rimonabant reduced the effects of smoked cannabis in two studies, but a reduction of subjective drug effects was not consistently observed. Since this research began, clinical use of rimonabant for any indication has been suspended because of the risk of adverse psychiatric effects. While this will preclude the use of rimonabant for the treatment of cannabis use disorders, these data indicate that cannabinoid receptor antagonists may be clinically useful in the treatment of cannabis use disorders should alternative compounds with better safety profiles be developed. That administration of fluoxetine has been associated with reduced cannabis use among depressed alcohol-dependent individuals suggests therapeutic potential. Replication of this effect is needed in either laboratory or clinical studies in which cannabis is the primary drug of abuse among participants. A laboratory study with lofexidine showed promise, but needs to be replicated. Finally, findings with buspirone, lithium and quetiapine have also been in a positive direction, but need to be verified using placebo controlled studies. The occurrence of adverse effects may also limit the use of these medications.

In conclusion, the need for identifying medications to improve treatment outcomes for cannabis dependence is clear. Medications should be used in conjunction with evidence-based psychosocial treatments to maximize clinical benefit, and some combination of multiple medications may be needed to achieve sustained abstinence in more severe cases. At this time, although it does not appear that we are close to the broad use of pharmacotherapies for cannabis dependence, several promising candidate medications have been identified. Continued research studies, particularly controlled clinical trials, are obviously needed for the medications that have demonstrated promise to date. Moreover, there are a number of compounds (e.g. second-generation cannabinoid receptor antagonists, fatty acid amide hydrolase [FAAH] inhibitors) for which mpreclinical data indicate potential for treating cannabis use disorders once they are approved for research in humans. It will be important for scientists and clinicians to continue to investigate these and other medications that could reasonably be considered to have therapeutic potential for treating cannabis use disorders.
Acknowledgements: We thank the US National Institute on Drug Abuse (Dr Vandrey: DA12471 and DA025794; Dr Haney: DA09236 and DA19239) for its support. Dr Vandrey also thanks the Johns Hopkins University School of Medicine Department of Psychiatry and Behavioral Sciences for support. The authors have no conflicts of interest that are directly relevant to the content of this review. E-mail: rvandrey@jhmi.edu

Source: Pharmacotherapy for Cannabis Dependence 553. CNS Drugs 2009; 23 (7)

TESTIMONY OF DAVID G. EVANS, ESQ.
EXECUTIVE DIRECTOR, DRUG-FREE SCHOOLS COALITION
BEFORE THE HEALTH AND HUMAN SERVICES
COMMITTEE OF THE NEW JERSEY ASSEMBLY
SEPTEMBER 20, 2004
TRENTON, NJ

IN OPPOSITION TO A-3256

SUMMARY OF THE TESTIMONY:

THE PUBLIC HEALTH BENEFITS AND SOCIAL EFFECTS OF NEEDLE EXCHANGE PROGRAMS ARE AT BEST UNCERTAIN, AND AT WORST ARE DEVASTATING TO BOTH ADDICTS AND THEIR COMMUNITIES

A.   NEEDLE EXCHANGE PROGRAMS ARE NOT SCIENTIFICALLY
       PROVEN TO REDUCE THE EPIDEMIC OF HIV OR HCV INFECTION
       AMONG INJECTION DRUG USERS

B.   NEEDLE EXCHANGE PROGRAMS DO NOT REDUCE SUBSTANCE
       ABUSE, BUT IN FACT FACILITATE AND ENCOURAGE SUBSTANCE
       ABUSE

C.   NEEDLE EXCHANGE PROGRAMS ARE DESTRUCTIVE TO THE
       COMMUNITIES IN WHICH THEY ARE USED

D.  NEEDLE EXCHANGE SENDS A BAD MESSAGE TO SCHOOL CHILDREN.
      PROVISION OF NEEDLES TO ADDICTS WILL ENCOURAGE DRUG USE.
      THE MESSAGE IS INCONSISTENT WITH THE GOALS OF OUR
      NATIONAL YOUTH-ORIENTED ANTI-DRUG CAMPAIGN.
 
A. NEEDLE EXCHANGE PROGRAMS ARE NOT SCIENTIFICALLY PROVEN TO REDUCE THE EPIDEMIC OF HIV OR HCV INFECTION AMONG INJECTION DRUG USERS 
 
(i) The New Haven Study

NEP activists frequently cite the results of a New Haven, Conn., study, published in the American Journal of Medicine, which reported a one-third reduction of HIV among NEP participants. However, the New Haven researchers tested needles from anonymous users, rather than the addicts themselves, for HIV.  They never measured “seroconversion rates,” which determine the portion of participants who become HIV positive during the study.  Also, sixty percent of the New Haven study participants dropped out; those who remained were presumably more motivated to protect themselves, while the dropouts likely continued their high risk behavior.

 Essentially, the New Haven study merely reported a one-third decrease in HIV-infected needles themselves, which, considering the fact that the NEP flooded the sampling pool with a huge number of new needles, is hardly surprising.  Even Peter Lurie, a University of Michigan researcher and avid NEP advocate, admits that “the validity of testing syringes is limited.”

Furthermore, the New Haven study was based on a mathematical model of anonymous needles using six independent variables to predict the rate of infection. The unreliability of any of the variables invalidates the result. The New Haven study also assumed that any needle returned by a participant other than the one to whom it had been given had been shared, and that any needle returned by the original recipient had not been shared. Both assumptions are suspect.   Also, the role of HIV transmission through sexual activity is downplayed. Prostitution often finances a drug habit. Non-needle using crack addicts have high incidence of HIV. Recent studies reveal that the greatest HIV threat among heterosexuals is from sexual conduct, not from dirty needles.   Less than one-third of the New Haven subjects practiced safe sex. In the New Haven study, sampling error alone could account for the 30 percent decline.
(ii) The HHS / NAS Study

In 1992, Congress directed the U.S. Department of Health and Human Services (HHS) to study NEPs. HHS in turn commissioned the National Academy of Sciences (NAS), an independent, congressionally chartered, non-government research center, to conduct the study.  According to the Congressional directive, if the NAS could show that NEPs worked and did not increase drug use, the Surgeon General could lift the ban on federal funding. The study was completed in 1995, and it concluded that well run NEPs could be effective in preventing the spread of HIV, and do not increase the use of illegal drugs. The NAS panel further recommended lifting the ban on federal funding for NEPs and legalization of injection paraphernalia. Now, seven years after the NAS study, Congress has yet to lift the NEP funding ban, clearly indicating that Congress maintains serious doubts as to the validity of the NAS/HHS conclusions regarding NEPs.  Of note is that study chairman Dr. Lincoln E. Moses cites the dubious New Haven study as a basis for the NAS findings.   The NAS panel admitted that its conclusions were not based on reviews of well-designed studies, and the authors admitted that no such studies exist.  Incredibly, the panel reported that “the limitations of individual studies do not necessarily preclude us from being able to reach scientifically valid conclusions.”

Two of the physicians on the NAS panel, Herbert D. Kleber, M.D. and Lawrence S. Brown, M.D., say the news media exaggerated the NAS’s findings. “NEPs are not the panacea their supporters hope for…We personally believe that the spread of HIV is better combated by the expansion and improvement of drug abuse treatment rather than NEPs, and any government funds should be used instead for that purpose.”   Dr. Kleber, executive vice president for medical research at Columbia University, added: “The existing data is flawed.  NEPs may, in theory, be effective, but the data doesn’t prove that they are.”  

This questionable NAS study represents the cornerstone research data used by the notoriously-politicized U.S. Department of Health and Human Services.  The pro-NEP advocacy of HHS, and its supporting data, has yet to convince Congress that NEPs are scientifically proven to reduce HIV infection while not increasing drug usage.

6 Id.
7  See Loconte, Joe, Policy Review, supra, note 2.
8  See New Jersey Family Policy Council, ANeedle Exchange Programs – Panacea or Peril, supra, note 1 
9    See Loconte, Joe, Policy Review, supra, note 2.
   (iii) The CDC Study

The Centers for Disease Control (CDC) conducted a study whose chief architect, Dr. Peter Lurie, recommended NEPs.  The CDC report calls for federal funds for NEPs and the repeal of drug paraphernalia laws
 
However, although the CDC study endorses NEPs, Dr. Lurie, the study’s author, acknowledges numerous problems:  None of the studies were randomized, and self reported behavior was often the basis for outcomes. Poor follow up and rough measurement of risk behavior also present problems, and he notes that syringe studies have limited validity. The report concludes: “Studies of needle exchange programs on HIV infection rates do not, and in part due to the need for large sample sizes and the multiple impediments to randomization, probably cannot provide clear evidence that needle exchange programs decrease HIV infection rates.”

(iv) The Montreal Study

A 1995 Montreal study, published in the American Journal of epidemiology, showed that IDUs who used the NEP were more than twice as likely to become infected with HIV as IDUs who did not use the NEP. Thirty three percent of NEP users and 13 percent of nonuser became infected.  There was an HIV seroconversion rate of 7.9 per 100 person years among NEP participants, and a rate of 3.1 per 100 person years among non-participants. 

A high percentage of both groups shared intravenous equipment in the last six months: 78 percent of NEP users and 72 percent of non-NEP users. Risk factors identified as predictors of HIV infection included previous imprisonment, needle sharing and attending an exchange in the last six months. The study authors stated: “We caution against trying to prove directly the causal relation between NEP use and reduction in HIV incidence. Evaluating the effect of NEPs per se without accounting for other interventions and changes over time in the dynamics of the epidemic may prove to be a perilous exercise.”  The study concluded:  “Observational epidemiological studies…are yet to provide unequivocal evidence of benefit for NEPs.” 
(v) The Vancouver Study
Vancouver has the largest NEP in North America, and was praised in the 1993 CDC report. It is financed by public funds, and by 1996 was distributing over 2 million needles per year.  A 1997 evaluation of the needle exchange program in Vancouver showed that since the program began in 1988, AIDS prevalence in intravenous users rose from approximately 2% to 27%.  This occurred despite the fact that 92% of the intravenous addicts in that jurisdiction participated in the needle exchange program.
 
The Vancouver study also found that 40% of the HIV-positive addicts who participated in the program had lent a used syringe in the previous six months, and that 60% of HIV-negative addicts had borrowed a used syringe in the previous six months.  Despite the enormous number of clean needles provided free of charge, active needle sharing continued at an alarming rate.  After only eight months, 18.6 percent of those initially HIV negative became HIV positive. 

The Vancouver study corroborates a previous Chicago study which also demonstrated that its NEP did not reduce needle-sharing and other risky injecting behavior among participants. The Chicago study found that 39% of program participants shared syringes, compared to 38% of non-participants; 39% of program participants, and 38% of  non-participants “handed off” dirty needles; and 68% of program participants displayed injecting risks vs. 66% of non-participants.
 
The Vancouver report noted that “it is particularly striking that 23 of the 24 seroconverters reported NEP as their most frequent source of sterile syringes, and only five reported having any difficulty accessing sterile syringes.”
The authors continue: “Our data are particularly disturbing in light of two facts:  first, Vancouver has the highest volume NEP in North America; second, HIV prevalence among this city’s IDU population was relatively low until recent years.  The fact that sharing of
injection equipment is normative, and HIV prevalence and incidence are high in a community where there is an established and remarkably active NEP is alarming.”  

What should be obvious from all of the studies above is that there is no conclusive scientific evidence that NEP’s arrest HIV infection.  Indeed, there is evidence that NEP’s breed HIV infection.

Some claim that the federal government supports NEPs. While the previous administration’s Department of Health and Human Services actively favored NEPs, those who were actually in charge of our national drug policy do not. General Barry McCaffrey, then director of the Office of National Drug Control Policy (ONDCP), when addressing the issue of NEPS stated “we have a responsibility to protect our children from ever falling victim to the false allure of drugs. We do this, first and foremost, by making sure that we send them one clear, straightforward message about drugs: They are wrong and they can kill you.” McCaffrey’s strong views influenced President Clinton not to approve federal aid money for NEPs.
A further elaboration of the ONDCP’s policy was provided by James R. McDonough, Director of Strategic Planning for ONDCP, who wrote:

       ‘  The science is uncertain. Supporters of needle exchange frequently gloss over gaping holes in the data — holes which leave significant doubt regarding whether needle exchanges exacerbate drug use and whether they uniformly lead to decreases in HIV transmission. It would be imprudent to take a key policy step on the basis of yet uncertain and insufficient evidence.

     The public health risks may outweigh potential benefits. Each day, over 8,000 young people will try an illegal drug for the first time. Heroin use rates are up among youth. While perhaps eight persons contract HIV directly or indirectly from dirty needles, 352 start using heroin each day, and more than 4,000 die each
     year from heroin/morphine-related causes (the number one drug-related cause of death).Even assuming that NEWS can further accelerate the already declining rate

  of  HIV transmission, the risk that such programs might encourage a higher rate of heroin use clearly outweighs any potential benefit.

    Treatment should be our priority. Treatment has a documented record of reducing drug use as well as HIV transmission. Our fundamental obligation is to provide treatment for those addicted to drugs. NEPS should not be funded at the expense of treatment.

Supporting NEPS will send the wrong message to our children. Government provision of needles to addicts may encourage drug use. The message sent by such government action would be inconsistent with the goals of our national youth-oriented anti-drug campaign.

NEPS do nothing to ameliorate the impact of drug use on disadvantaged neighborhoods. NEPS are normally located in impoverished neighborhoods. These programs attract addicts from surrounding areas and concentrate the negative consequences of drug use, including of criminal activity. 

 (vi) Among IV drug users, HIV is transmitted primarily through high-risk sexual      contact
 
Another reason why NEPs may not retard the spread of HIV is that HIV is transmitted primarily through high-risk sexual contact, even among IV drug users.  Contrary to prior assumptions, recent studies on the efficacy of NEPs have discovered that it is not needle exchange, but instead, high-risk sexual behavior which is the main factor in HIV infection for men and women who inject drugs, and for NEP participants. A recently released 10-year study has found that the biggest predictor of HIV infection for both male and female injecting drug users (IDUs) is high-risk sexual behavior and not sharing needles. High-risk homosexual activity was the most significant factor in HIV transmission for men and high-risk heterosexual activity the most
significant for women.  The study noted that in the past the assumption was that IDUs who were HIV positive had been infected with the virus through needle sharing.

The researchers collected data every 6 months from 1,800 IDUs in Baltimore from 1988 to 1998. Study participants were at least 18 years of age when they entered the study, had a history of injection drug use within the previous 10 years, and did not have HIV infection or AIDS. More than 90 percent of them said they had injected drugs in the 6 months prior to enrolling in the study. In their interviews, the participants reported their recent drug use and sexual behavior and submitted blood samples to determine if they had become HIV POSITIVE since their last visit. The study showed that sexual behaviors, which were thought to be less important among IDUs, are the major risk for HIV seroconversion for  both men and women. 

If the above conclusions are correct, the very presumption of NEP efficacy becomes suspect.  Indeed, the use of needle exchange programs to address a problem which is caused primarily by high-risk sexual behavior would seem to be highly misguided.

Another reason that Needle Exchange Programs do not effectively address the issue of “saving lives” is that HIV (regardless of how it is contracted) is not the primary cause of death for IVUs.  A study conducted at the University of Pennsylvania followed 415 IV drug users in Philadelphia over four years.  Twenty eight died during the study.  Only five died from causes associated with HIV.  Most died of overdose, homicide, suicide, heart or liver disease, or kidney failure.

Clean needles, even if they in fact prevent HIV, will do nothing to protect the addict from numerous more imminent fatal consequences of his addiction.  It is both misleading and unethical to give addicts the idea that they can live safely as IV drug abusers.  Only treatment
and recovery will save the addict.  The myth of “safe IV drug use” is a lie which is perpetuated by NEPs, and it is a lie which will tend to kill the addict, although his corpse may be free of HIV, for whatever consolation that will provide to the NEP proponent.  
B. NEEDLE EXCHANGE PROGRAMS DO NOT REDUCE SUBSTANCE ABUSE, BUT IN FACT FACILITATE AND ENCOURAGE SUBSTANCE ABUSE.

The rise of NEPs, with their inherent facilitation of drug use (coupled with the provision of needles in large quantities), may also explain the rapid rise in binge cocaine injection which may be injected up to 40 times a day. Some NEPs encourage cocaine and crack injection by providing “safe crack kits” with instructions on how to inject crack intravenously.  Crack cocaine can be, and generally had been, ingested through smoking.  But the easy and plentiful availability of needles facilitates crack injection, creating a new segment of IV drug users, subject to health dangers they would otherwise have been spared exposure to.  In some NEPS, needles are provided in huge batches of 1000, and although there is supposed to be a one-for-one exchange, the reality is that more needles are put out on the street than are taken in.

NEPs also facilitate drug use through lax law enforcement policies.  Police are instructed not to harass addicts in areas surrounding NEPs. Addicts are exempted from arrest because they are given an anonymous identification code number. Since police in these areas must ignore drug use, and obvious and formidable disincentive to drug use disappears.  As the presence of law enforcement declines in these areas, the supply of drugs rises, with increased purity and lower prices, attracting new and younger consumers. 

Many drug prevention experts have warned that the proliferation of NEPS would result in a rise in heroin use, and indeed, this has come to pass. (However, the increase in drug use was ignored by the federally-funded studies which recommended federally funding NEPS). The National Center on Addiction and Substance Abuse at Columbia University reported August 14, 1997 that heroin use by American teens doubled from 1991 to 1996.  In the past decade, experts
estimate that the number of US heroin addicts has risen from 550,000 to 700,000. 
In 1994, a San Francisco study regarding a local NEP falsely concluded that there was no increase in community heroin use because there was no increase in young users frequenting the NEP.  The actual rate of heroin use in the community was not measured, and the lead author, needle provider John Watters, was found dead of an IV heroin overdose in November 1995. According to the Public Statistics Institute, hospital admissions for heroin in San Francisco increased 66% from 1986 to 1995.

In Vancouver, site of the largest NEP in North America, heroin use has risen sharply.  In 1988 when the NEP started, 18 deaths were attributed to drugs.  In 1993, 200 deaths were attributed to drugs. A 1998 report notes that drug deaths were averaging 10 per week.  Now Vancouver has the highest heroin death rate in North America, and is referred to as Canada’s “drug and crime capital.”

The 1997 National Institutes of Health Consensus Panel Report on HIV Prevention praised the NEP in Glasgow, Scotland, but the report failed to note Glasgow=s massive resultant heroin epidemic. Subsequently, as revealed in an article entitled “Rethinking Harm Reduction for Glasgow Addicts,” Glasgow took the lead in the United Kingdom in deaths from heroin overdose, and its incidence of AIDS continues to rise. 

Boston’s NEP opened in July 1993, and the city became a magnet for heroin. Logan Airport has been branded the country’s “heroin port.”  Boston soon led the nation in heroin purity (average 81%), and heroin samples of 99.9% are found on Boston streets. Subsequently, Boston developed the cheapest, purest heroin in the world and a serious heroin epidemic among the youth.  The Boston NEP was supposed to be a “pilot study,” but there was no evaluation of seroconversion rates in the addicts nor of the rising level of heroin use in the Boston area.

Similarly, the Baltimore NEP is praised by those who run it, but the massive drug epidemic in the city is overlooked.  The National Institute of Health reports that heroin treatment and ER admission rates in Baltimore have increased steadily from 1991 to 1995. At one open-air drug supermarket (open 9 a.m. to 9 p.m.) customers were herded into lines  sometimes 20 or 30 people deep. Guarded by persons armed with guns and baseball bats, customers are frisked for weapons, and then allowed to purchase $10 capsules of heroin.
One thing should be clear from the foregoing: since the implementation of NEPs, heroin use in our country has boomed.  It is obvious:  a public policy of giving needles to heroin addicts facilitates and encourages heroin use. 
C. NEEDLE EXCHANGE PROGRAMS ARE DESTRUCTIVE TO THE COMMUNITIES IN WHICH THEY ARE USED.

Most citizens oppose NEPs in their communities, and are concerned about the prospect of dirty needles being discarded in public places.  These fears are not without merit.  NEPs distribute millions of needles every year, and there is little or no accountability for needles once they have been distributed.  A survey conducted in 1998 revealed that in that year 19,397,527 needles handed out, and at best 62% were exchanged, leaving 7-8 million needles unaccounted for.   Carelessly discarded needles create a well-documented public hazard:

* On February 11, 2001, a six-year old from Glade View, Florida, stabbed five children with a discarded syringe. (Kellie Patrick/Scott Davis, “Playground Attack Raises Health Worries,” Sun Sentinal, 2/9/00, p 1B).

* On February 2, 2001, a nine year old from the Bronx stabbed four children with a discarded needle. (Diane Cardwell, “Boy Accused of Needle Attack,” The New York Times, 2/2/01, p. A17.)

* On February 13, 2001, a syringe left at a bus station stuck a four year old boy. (Mike Hast, “Big Fines for Syringe Litterers,” Frankson & Hastings Independent, February 13, 2001,www.mapinc.org/drugnews/v01/n304/ a08.html.)

Besides the physical hazard created by discarded needles, there is a commonsense perception that NEPs bring an air of decay to the communities that host them.  After several years of operation, 343 Massachusetts towns and cities (out of a total of 347) continue to decline the option of approving a local NEP, although of the 10 available slots, only 4 are taken.
31  Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, HHS,       Washington, DC 2001;50:384-388. 
32  Maginnis, Robert L., 2001 Update On The Drug Needle Debate, Insight, Number 235, July 16, 2001, Family Research Council, 801 G. St. NW, Washington, DC 2001.
In March 1997, accompanied by a New York Times reporter, a member of the Coalition for a Better Community, a New York City group opposed to NEPs, visited the Lower East Side Needle Exchange. She was not asked for identification and was promptly given 40 syringes (without having to produce any to exchange).  She was also given alcohol wipes and “cookers” for mixing the drugs, and she was given an exchange ID card that would exempt her from arrest for possession of drug paraphernalia. She was then shown how to inject herself. 

Community opposition to the Lower East Side Needle Exchange arose soon after implementation of the local NEP due to an increase in dirty syringes on neighborhood streets, in school yards and in parks. There was observed to be a dramatic increase in the public display of injecting drugs.  NEP users were seen selling their syringes to buy more drugs. Exchange workers themselves were photographed selling needles offsite.  Neighbors perceived the Lower East Side NEP as little more than a wholesale distribution center for clean needles and a social club for addicts. 

Pro-needle activist Donald Grove concurred: “Most needle exchange programs actually provide a valuable service to users beyond sterile injection equipment. They serve as sites of informal organizing and coming together. A user might be able to do the networking to find good drugs in the half an hour he spends at the street based needle exchange site networking that might otherwise have taken half a day. [Grove, D. The Harm Reduction Coalition, N.Y.C., Harm Reduction Communication, Spring 1996].

In 1998, a U.S. Government official was sent to Vancouver, site of the largest NEP in North America, to assess the high incidence of HIV among NEP participants, and the skyrocketing death rate due to drug overdose.  He reported that the highest rates of property crime in Vancouver were within two blocks of the needle exchange.  He also observed, pursuant to a tour with the Vancouver Police, that there was a 24 hour drug market and plain view injection activity in the area immediately adjacent to the needle exchange.  Most poignantly, he was told, in a private interview with an elementary school teacher, that the children at area schools are not allowed outside at recess for fear of needles. 
CONCLUSION

There is ample evidence to suggest that very fundamental premises used to justify and support NEPs are seriously flawed.  First, NEP participants routinely continue to share needles and large percentages of the NEP participants are HIV positive, meaning that NEPs do nothing more than continue the spread of HIV (and HCV).  Significantly, no one has been able to explain satisfactorily why enhanced needle availability in and of itself would discourage needle sharing: needle sharing is an intrinsic aspect of IV drug use, and a NEP-issued needle will transmit HIV as well as any other needle.

Second, NEP studies have discovered (inadvertently) that needle sharing is not even the primary cause of HIV infection for IVUs.  It is primarily through high-risk sexual behavior that IVUs contract HIV; free needles do nothing to prevent sexually transmitted disease.  Furthermore, HIV (regardless of how it is contracted) is not even the primary cause of death for IVUs.  Most die of overdose, homicide, suicide, heart or liver disease, or kidney failure.  Clean needles may protect an addict from HIV, but they do nothing to protect him from the more numerous, and more imminent fatal threats of his addiction.  Several key NEP proponents have died of heroin overdose; no doubt their needles were very clean.

Third, the science is inconclusive.  Although the proponents of NEPs uniformly aver that the scientific debate regarding the efficacy of NEPs is over, in truth, even the reports favoring NEPs are burdened with imprecise methodology, and many of the authors of those reports caution that their results should not be deemed conclusive. Today, there is still no conclusive scientific evidence: (1) that NEPs reduce the spread of HIV and HCV, or (2) that NEPs do not encourage IV drug use.  Indeed, the correlation between the rise of NEPs and the explosion of IV drug use, if it is a coincidence, is a remarkable one.  Dispassionate observers will look at the current epidemic of heroin and IV cocaine use as a tragedy which might have been averted, or mitigated, but for the misguided mercies of the NEP concept.
 
Fourth, while the benefits of NEPs may be in doubt, the costs to the surrounding communities are very real.  The overwhelming majority of communities dread the prospect of a local NEP, for self-evident and well-documented reasons.

 34  D.B. Des Roches, Information, Memorandum for the Director, Through: the Deputy Director, Subject: Vancouver Needle Exchange Trip Report, Executive Office of the President, Office of National Drug Control Policy, Washington, D.C. 20503, April 6, 1998.

 Peer-based addiction recovery support: history, theory, practice, and scientific evaluation.
White W.L.
Chicago, IL: Great Lakes Addiction Technology Transfer Center and Philadelphia Department of Behavioral Health and Mental Retardation Services, 2009.
This monograph is likely to become the handbook for the growing peer-based recovery movement in the UK. For administrators, the approaches it reviews offer a way to reconcile decreasing per-patient resources with a policy agenda now focused on reintegration and recovery.
Abstract This seventh monograph* in a series on recovery management and recovery-oriented systems of care synthesises knowledge about the history, theoretical foundations, methods, and scientific status of peer-based recovery support for individuals with the most severe and complex alcohol and other drug problems. It was written primarily for people directly involved in planning, funding, delivering, supervising, and evaluating peer-based recovery support services, but will also be of interest to policymakers, purchasers of care, treatment programme administrators, and addiction counsellors and other service professionals. Though rigorously researched, information is presented in a clear and accessible language.
The report focuses on:
• Peer-based recovery support in general, meaning any form of mutual assistance aiming for long-term recovery from alcohol and other drug problems. Such assistance can and often does occur informally. The focus here is primarily on recovery support provided through recovery mutual aid societies and abstinence-based religious and cultural revitalisation movements by people whose credentials rest on personal experience.
• Peer-based recovery support services, a narrower term for assistance directed toward the same goal but delivered through more specialised roles with more formal resources, service protocols and safeguards. The key distinction is the term ‘services’, which implies a more formal structure though which recovery support is delivered. Here the focus is on recovery community organisations other than mutual aid societies, and on peer-based services provided through addiction treatment programmes and allied health and human service agencies. These services are distinguished from other programmes by their: mobilisation of personal, family, and community recovery capital to support long-term recovery; respect for diverse pathways and styles of recovery; focus on immediate recovery-linked needs; use of self as a helping instrument; and their emphasis on continuity of recovery support over time.
After comprehensively reviewing the literature and profiling peer-based recovery support initiatives, the author reached (among others) the following conclusions:

• Peer-based recovery support services are today growing out of the failure of addiction treatment to provide a continuum of care that is accessible, affordable, and capable of helping people with the most severe and complex problems move beyond brief episodes of recovery initiation to stable long-term recovery.

• Their distinctive strategy is to improve linkage to recovery mutual aid groups and other recovery support institutions, and their value is founded in what specifically those in recovery bring to the helping process. As with any effective helpers, those in recovery relate not primarily through techniques, but through humanness. They are able to do so, not because they once experienced addiction, but because they completed their own recovery experiences and emerged as men and women committed to this demanding way of life.

• Peer-based models of care can have a transforming effect on larger systems of care and on our society, but can also be corrupted and devoured when integration in to these systems leads to pressure to emulate the ethos of current professional treatment models. Care must be taken not to over-professionalise the roles of peer helpers, but training, guidelines, supervision and recognising the limits of one’s competence and role, are as important for services based on the power of mutual identification as for professional services.

• Rather than view peer-based and professional-based styles of knowing and doing as antagonistic models rivalling for superiority, it is more helpful to view these approaches as complementary. We need a community in which both professional and peer-based services are available as needed, and are supported and integrated into a seamless system of long-term recovery support.

• One unique quality separates the addictions field from peer models in allied fields: the growth of spiritual, secular, and religious recovery mutual aid groups, and new recovery support institutions, has gifted it the oldest and largest recovery mutual aid network in the world. New peer-based models must capitalise on these strengths rather than undermining or replacing them. The long-term goal is not to create a larger treatment system or new profession, but the establishment of recovery support relationships that are non-hierarchical, non-commercialised, and enduring in recovery-friendly communities.

• The question, ‘Who is most qualified to treat the alcoholic?’ is ill-framed because it assumes a homogeneity within the label ‘alcoholic’ and within the boundaries of particular helping roles or categories of helpers. In terms of recovery status, the question is not whether professional and peer helpers with or without a history of addiction recovery are most effective, but which helper is most effective with which person or family at a particular point in time. There are so many kinds of alcoholics and so many different kinds of alcoholism that a therapist eminently qualified to treat one type may fail completely with another.

• Recovery stages might be broadly conceived in terms of:
• 1 a sudden or unfolding opportunity for change;
• 2 a commitment to recovery experimentation;
• 3 recovery initiation and stabilisation;
• 4 recovery consolidation and maintenance; and
• 5 enhanced quality and meaning of life in long-term recovery.
 Peer-based recovery support services will probably be found most critical in stages 1, 2, and 4. Traditional professionals may be most effective in stages 3 and 5.
Every effort has been made to meticulously document sources, but many critical research questions about peer recovery support have yet to be studied and many studies suffer from methodological problems, so these findings are best viewed as probationary, pending new studies of greater methodological sophistication.
Though written by an advocate of peer-based recovery, this monograph is careful to adhere to the research (more comprehensively reviewed here than in any other publication) and to point out the limitations and risks involved in this route to recovery and the continuing role of professional treatment and other formal services. In it the British reader will find unfamiliar but potentially promising manifestations of mutual aid such as recovery social clubs, recovery community centres, and recovery homes, with profiles of how these have worked in practice and relevant research. Attention is not limited to 12-step based approaches, but extends to mutual aid based on other philosophies and understandings of addiction and recovery. For the growing peer-based recovery movement in the UK, it is likely to become an essential handbook to clarify thinking, offer practical ways forward, identify pitfalls and risks, and to encourage further research.
As the author comments, most of the reviewed research lacks the methodological safeguards of a randomised trial or some other research design capable of eliminating influences on outcomes other than mutual aid or peer support. Typically studies have recorded the degree to which substance dependent individuals participated in mutual aid activities and groups, and then assessed how closely this was associated with substance use and related problems. Such designs leave open the possibility that good outcomes encourage increased mutual aid participation rather than the reverse, or that people who are in any event going to do well also tend to participate in whatever in that society is the accepted route to doing well in terms of recovery from addiction. In the USA, where most studies originate, that route entails 12-step mutual aid.
When (as in a review for the Cochrane Collaboration) the focus is limited to the few randomised or other well controlled trials, there is no convincing advantage for 12-step mutual aid or allied services over other approaches. This review was unable to take in to account an influential later study which randomly assigned patients in formal treatment to standard versus intensive referral to 12-step groups. As intended, intensive referral improved 12-step mutual aid participation and this in turn improved substance use outcomes, confirming that participation was indeed an active ingredient. However, the effects on both participation and substance use were not great. While such studies can demonstrate the value of the extra element of mutual aid participation they ‘artificially’ generate, they say nothing about the value of the bulk of mutual aid participation as it naturally occurs. For this we must turn to the less well controlled studies excluded from the Cochrane review but included in the featured report, yet these are not capable of delivering convincing answers. This bind arises from the fact that mutual aid cannot be imposed or withheld by researchers and the results observed. Rather, it is generated (or not) organically by the nature of the society and of the individuals who choose (or not) to participate. It makes little sense to ask what the recovery chances of that society or those individuals would be if they did not generate or participate in mutual aid, because then they would not be the same societies or individuals. Another limitation of the controlled research is that typically it has studied mutual aid as an add-on to current treatment models, not the thoroughgoing systemic transformation called for in the featured report.
Even if given these difficulties, peer support and mutual aid struggle to demonstrate a superiority, where they can have a distinct advantage is in accessibility and (by reducing resort to public services) cost to society. For administrators in the UK, such approaches offer a way to reconcile increasing numbers in treatment, decreasing per-patient resources, increasing pressure to move patients through and out of treatment, and a policy agenda now focused on secure reintegration and recovery. Formal services seem unlikely to be able to make major advances in the availability to dependent substance users of (among other supports to reintegration and recovery) supported housing, suitable training and education opportunities, sheltered, graduated and attractive employment, and satisfying non-drug focused social and lifestyle options. Within available resources and political and public willingness to redirect these, transformations of the kind described in the featured report may be the only feasible way to create a more recovery-friendly environment which can protect greater numbers of people leaving treatment from repeated relapse.
However, risks of the kind warned about in the report are already apparent in parts of Britain where services concerned to safeguard vulnerable adults and who have clinical responsibility for patients seem reluctant to refer those patients to untried and unqualified mutual aid organisations, leading to pressure for those organisations to implement safeguards and protocols potentially antithetical to their self-help ethos. Such pressures have also been apparent in the UK mental health service-user/survivor movement. There is also a tendency for mutual aid recovery enthusiasts to see formal treatment services and their workers as ‘part of the problem’ rather than collaborators. The result is an imperfect interface between mutual aid and formal services which impedes beneficial complementarity and movement between them. As with other collaborations between organisations with different traditions and agendas, these difficulties will need to be carefully and respectfully worked through if patients are to benefit maximally from the potentially huge reservoir of voluntary effort represented by current and former problem substance users.
In the UK employment of current or former problem substance users in drug and alcohol services may be seriously impeded by the new requirements and powers associated with the advent in 2009 of the Independent Safeguarding Authority and of a similar scheme in Scotland. Among the criteria for banning people working with vulnerable adults (which would embrace many attending drug and alcohol services) are a history of acquisitive crime or fraud, addictive behaviour, or persistent offending. Such histories are common among drug addicted populations who have recovered through treatment and who might be employed as a paid employee or volunteer to offer peer-based support to substance users in contact with services. These problems have been recognised and representations are being made to the authority.
SOURCE: Peer-based addiction recovery support: history, theory, practice, and scientific evaluation.
White W.L.
Chicago, IL: Great Lakes Addiction Technology Transfer Center and Philadelphia Department of Behavioral Health and Mental Retardation Services, 2009.

Fred M. Jacobs, M.D., J.D., Commissioner,
New Jersey Department of Health and Senior Services
August 2007

Dear Dr. Jacobs,

Re: Establishment of Needle and Syringe Programs

I understand that the state of New Jersey is considering a needle and syringe “exchange” program. I am also advised that New Jersey is a liberal democratic society whose members for the most part believe in freedom of the individual to pursue “life, liberty and happiness”. This of course is wonderful! And also provides a useful opportunity to note that no drug addict enjoys real freedom while their will, their lives, their relationships and their resources are largely dedicated to the service and slavery of their chemical addiction. This would make your lovely part of the world an excellent place in which to pursue those liberties which should be the birthright of every human being.

To introduce myself I am a family physician in Australia, and have pursued a special interest in the treatment of addiction especially for heroin, but also other drugs of addiction for the last ten years. Health department figures indicated last year that in the years 2001-2006 I single handedly registered 11,000 of the 14,000 registrations for opiate detoxification in the state of Queensland. I have also attained one of the three largest numbers of naltrexone based rapid opiate detoxifications in the country of Australia with over 1,800 procedures performed including 600 naltrexone implants. This was done with only two overnight hospital admissions which is a world safety record. I have also submitted evidence to several Government committees and leaders on the subject of drug policy.

As the so-called “needle “exchange” programmes” make little effort to exchange syringes, and as actual exchange makes little difference to the operation or mission of the programs, it is probably more accurate to refer to them as needle and syringe distribution programs, or NSP’s. It is important that your community appreciate this because syringe disposal is a real problem with these facilities. It has been so in this country. Our lovely and world famous Bondi beach in Sydney is now said to be one of the best places in the country to get a needle stick injury, due to the many syringes hidden in the sand. Clean up patrols have operated in King’s Cross twice daily for years to clean up the extreme public nuisance of hundreds of used syringes left dangerously in the streets and side walks, to protect the public . This is a well recognized problem with NSP’s which is generally covered up while such programs are in the planning phase.

Epidemiological Evidence

Since the NSP experts readily resort to discussion of “evidence based treatments”, and since the community decision to fully implement this program has such far reaching implications both in terms of needle disposal bins in all public toilets and for the time and direction of public health policy in the management of addiction, it is very appropriate that careful consideration be given to the quality of evidence which is typically cited in support of NSP’s. In particular the evidence based literature waxes lyrical about “levels of [reliability of] evidence.”

Self-report data is widely used in the addiction literature but it has been shown many times to be highly flawed and unreliable, and to fails to correlate with more objective and hard signs of HIV rates. As was pointed out to you by Dr. Fred Payne’s letter, and as was noted in the Institute of Medicine Report on this subject, it is well recognized that most of the literature on the subject of needle exchange is based on self report. This would clearly make it the least reliable form of evidence by their own criteria. Actually one would have to wonder if the evidence based gurus would accept such data at all.

Secondly we are aware of the “ecological” studies where they repeatedly report many cities with and without NSP’s. The work of Dr. Kirsten Kall’s group from the University of Linkoping shows clearly that in such an epidemic the rate of rise of the epidemic is related to the population at risk. Epidemics it is argued have a natural life history with a rise, fall and usually stabilization levels. Depending where in the natural history of the epidemic one takes one’s samples one will get a different picture of the efficacy of the NSP’s. It is for this reason that showing either a rise or a fall in HIV incidence or prevalence after NSP introduction is irrelevant if one is not informed of the natural history of the epidemic, and unless one can adduce by other means the likely outcome in its absence. This is a severe criticism, and one which effectively invalidates the whole of this genre of studies. I am also assured by epidemiologists familiar with such matters, that such studies are given no weight in epidemiological circles for this reason. That they have been foisted upon the rest of the world and even mentioned in major UN reports shows the degree to which such sloppy unscientific methods have been adopted within such agencies.

Indeed Dr. Alex Wodak, understood to be one of the primary authors of the relevant section of the 2006 UNAIDS report which eulogized NSP’s and the harm minimization addiction management paradigm, unequivocally stated in 1995 that formal proof of the methods of harm minimization would be impossible as it would not be possible to control in real life the many confounding factors which would be acting, and thereby prove that any particular intervention alone had been salient in controlling the target disorder .

Furthermore there is a clear conflict of interest by some of the leading proponents of NSP’s . Dr. Alex Wodak was for many years the President of the International Drug Law Reform Foundation and is the current president of the Australian Drug Reform Foundation which lobbies unceasingly for drug decriminalization. Dr. Don Jaralais in the USA is also understood to be of a similar ideology, and his advocacy for NSP’s is well known. I am of the understanding that such parallels could be made repeatedly for many of the most ardent advocates of NSP’s.

Dr. Payne’s letter mentions the very high rates of HIV in Vancouver at present despite the operation of an NSP, having risen from 1% to 35%. It was also shown long ago in Montréal that the HIV rate amongst NSP attendees was 2.5 times that amongst non-attendees (3.1 Vs. 7.9%) .

In terms of its control of other virus transmission NSP’s seem to substantially lack power. They failed to control Hepatitis B in Amsterdam , or Hepatitis C in Australia where rates of HCV carriage amongst IVDU who have been involved in the lifestyle for longer than six months exceed 80%.

Special Situations

Some situations are special and require special consideration. We are well aware that the apparent success of harm minimization techniques in this country is frequently cited overseas and in international fora as proof of principal of the efficacy of harm minimization epidemic management techniques. What is repeatedly overlooked in such discussions is our record rates of other infections such as Hepatitis B and C, and the venereally transmitted agents Herpes, Warts and Chlamydia. Indeed recently released data shows 30-100% growth in the last five years in Queensland in Gonorrhea, Hepatitis C, Chlamydia and Syphilis . Indeed it has been estimated that the Australian health care system has now to plan for over 100,000 liver transplants required for Hepatitis C alone in the next 20 years. One also notes that the outcome after transplantation for Hepatitis C is inferior to that for other infections due to the universal early graft re-infection which invariably occurs in the first few post-operative days, and the clash between anti-rejection immunosuppressive therapy and the anti-viral needs of fighting an aggressive viral infection in the context of the immuno-suppression and likely immuno-senescence induced by drug addiction, which is reversed to an unknown extent by abstinence.

In Australia our HIV rate amongst IVDU who do not share other risk factors is very low by international standards of the order of 1%. New cases of HIV nationally in all groups have risen from about 100 in 1991 to around 300 in 2005 . There appears to be significant variation in the estimates for the number of syringes distributed to addicts in this country with estimates varying from 20,000,000 to 200,000,000 – a level of inexactitude which in itself should give us pause. The former number was more than our total population at the time, and the latter number is substantially greater than the number of sheep here (which says a lot for a nation which for a long time was said to ride on the sheep’s back!) One important feature then facing the advocates of any NSP program is exactly how many syringes do they want to distribute? One for every man woman and child in the state?

However in the case of Australia we would do well to heed Wodak’s warnings about the inability to control for other confounders. From a modeling point of view the epidemic began in certain well known high risk groups. Its spread would then have been related to the population at risk, the activity of the various risk taking behaviours, and the intersection of these behaviors with the wider general community. Still today over half of all HIV infections in this country occur amongst men who have sex with men. It should also be added that the rate of IVDU in this group is 10-20 times higher than it is in the general community. Clearly then the spread of the disease into the wider community is related to the behaviour of this reservoir of infected people. One of the obvious confounding factors which has never been studied or quantified is what might be termed the homosexualization of the Australian culture with many laws, many bureaucracies, and schools of public health completely subsumed by the new ideology accompanying the public health impetus of the HIV epidemic. In that this likely instilled major good will in the primary target community, and is likely to have very positively influenced the relevant risk taking behaviours, it is clearly an intimate confound which confuses and likely dilutes any effects which might be attributable strictly to NSP’s.

Another important confounding factor was that Australia made treatment for HIV free to all patients who would have benefited from it from the outset of the epidemic. Assuming that the most at risk individuals were infected near the beginning of the epidemic, then those that survived their infection might reasonably be expected to have had a lower viral load for most of this time making them les infectious. This can be expected to have significantly slowed the rate of progression of the epidemic in this country.

Sweden is an important case in point which must be mentioned in any intelligent discussion of the NSP movement. Sweden has very limited methadone treatment availability, until recently no NSP activity, and no legal “shooting galleries” and a very low rate of HIV in IVDU. Hence the methods of harm minimization cannot strictly be said to be required for HIV control. Clearly HIV control can occur in a very effective manner in the absence of the model harm minimalist strategies.

The situation in prisons, or penitentiaries, is a special one and well worth at least some specific consideration. I was privileged to give evidence to the Inquiry into the Impact of Illicit Drug Use on Families before the Federal House of Representatives of the Australian Parliament on 3rd April 2007 . During that interview I stated that “my blood ran cold at the thought of 500 inmates all sharing the same syringe barrel” as was recounted to me by one of my HIV positive patients. However typical harm minimalist solutions such as methadone, syringe distribution and bleach use have been found to be impractical in the prison environment, and in this country have triggered strikes and industrial disputes by the prison warders due to the creation of unsafe workplaces. Since making those comments to the committee I have considered what might best be done about this appalling situation. One approach follows below (see “Other Treatment Modalities”).

In essence it is my belief that where the crime for which a person is committed is referable to opiate drugs, the standard of care will become naltrexone implant insertion on admission to the jail (after appropriate detoxification procedures), naltrexone implant maintenance during incarceration, and naltrexone implant prior to discharge to prevent the overdose which so often accompanies discharge (and the ritualistic “get a whack, get a woman” routine which is invariably followed). Indeed in Perth patients discharged from the prison are taken by volunteer escort from the prison gates to the clinic for implantation before the whole destructive cycle can re-commence. This seems the most sensible, responsible and compassionate management of this problem.

Other Treatment Modalities

Naltrexone was fist synthesized in the USA 1963 at Endo laboratory by Matossian acting under Blumberg’s instruction . Naltrexone implants and depot preparations have recently received a lot of attention from the international addiction management literature, and have been commercially introduced in the USA. American developed depot injections typically last 3-4 weeks. A preparation recently developed in this country lasts typically 4-6 months. The results of the first formal clinical trial conducted in Perth will soon be announced, probably in a leading medical journal such as JAMA or New England Medical Journal. They have been extensively used in this clinic where we have inserted over 600 USA (Wedgewood) and Australian (Perth “Go Medical”) implants. I was asked by the Preventative and Community Medicine Committee of the Queensland Faculty of the Royal Australian College of General Practitioners to evaluate naltrexone medicine including the Perth naltrexone program in 1998, and since 2001 I have been involved with the development in Perth of their naltrexone implant.

Unofficially the abstinence rate in terms of not returning to dependent heroin use at five months was well in excess of 50% in a study which set new standards international medical literature for patient follow-up. Only 11% of the 70- patients were lost to follow-up compared to over 90% in a similar (larger) study conducted in leading centres in the USA reported by Hollister in 1977 for NIDA at the NIH . Naltrexone is also a widely recognized and used technique for reducing problem drinking in alcoholics. It has also been used for gambling addiction, with positive results on some occasions. Moreover other results reported from the Perth clinic indicate that naltrexone is likely to have a controlling effect on other chemical addiction such as benzodiazepines, cannabis and stimulants such as amphetamines.

It is my personal view that they are excellent and will soon revolutionize the treatment of opiate addiction. Opiate dependence of course is the most addictive and refractory of all drug addictions, and the possibility of gaining control of such patients in a drug free context, as opposed to the usual medical model involving the indefinite maintenance of addiction, must be one of the most exciting opportunities ever to be offered to physicians in addiction medicine.

Another medical agent which has shown enormous promise in the control of multiple addictions is the cannabinoid antagonist rimonabant (“Accomplia”; SR141716A) which has been used with success against opiate, tobacco, alcohol, amphetamine food and cocaine addictions. This drug has attracted attention from NIDA and is undergoing further testing. I am not sure what its regulatory status is in the USA. It was available in eight European nations when I enquired with the pharmaceutical company (Sanofi-Synthelabo) about four months ago. The drug is still under patent, so this impedes its being re-formulated into an implant or depot preparation.

The combination of naltrexone and rimonabant has yet to be tested but would appear to show obvious promise, and it would be a priority in a rational testing program to investigate this further.

Future Research Directions

Many studies show increased evidence of drug use in young people.

All senior authorities in the world agree that there is far too little resources put towards investigating the toxicological effects of addictive drugs in general, and in adolescents in particular.

If we are ever going to do more than shut the door after the horse has bolted, clearly the issue of the true toxicity of addiction must be much better investigated, and the results of such studies broadcast far and wide to our young people, to de-glamourize the dreadfully seductive marketing program to which the rock music and popular culture misleadingly subjects them. If we are ever going to contain the monster of rampant destructive drug use in our younger people, then their dangers must be better emphasized.

Given the obvious multi-system damage of long term chemical addiction which is immediately apparently to even the untrained observer, one can only conclude which a Science which espouses the relative benignity of addiction must be grossly and egregariously deficient.

I have formulated a detailed plan by which such a strategy can be put in place, based around the accumulated ageing changes evident in the skin, teeth, hair, blood vessels, bones, immune system, stem cells and brains of addicts. It invites international collaboration and multi-system multilevel cooperation and the application of state of the art techniques to classical clinical problems. That however, is another story.

CONCLUSION

In summary NSP’s incur great social cost and are clearly part of the problem rather than part of the solution. Their scientific literature is remarkable for its lack of compelling evidence and methodological rigor, not to mention the prominence of adverse findings, when properly adjudicated. Rather the global penetration of NSP’s is an indicator of the strength of the marketing strategy of the ideology they enshrine. They are in any case about to be phased out like old dinosaurs by the cutting edge technologies which are moving ever closer to being a real market alternative, particularly the revolutionary long lasting Australian naltrexone implant.

I have been advised that now methadone is worth $150/week to dispensing hospitals in Federal hospital subsidies. As some of the most famous institutions in the USA have 10,000 – 20,000 patients enrolled on it, this income source forms a major stream of hospital funding. As such it is not likely to be disrupted. What the management of the Australian HIV epidemic does teach us is that it is best to get on and treat the HIV infection as soon as medically appropriate. In addiction medicine we have up until now largely done the reverse, for there we have deliberately continued indefinitely maintenance treatment designed to not to confront the addicted physiology, but rather to postpone indefinitely the definitive redress of that medical condition. The Australian success with HIV management tends to rather emphasize the reverse approach. This is the therapeutic route suggested by naltrexone implant maintenance. In all the discussion we would appear to have forgotten that in the early 1960’s New York was in urgent need of a treatment for addicted GI’s returning home from Vietnam. Methadone as the only medical solution then available was adopted and quickly came to command tremendous official support to the point where it became in time, the established industry. We have now a far more exciting opportunity to launch naltrexone implants and other new treatments in a similar and innovative manner. In would be my sincere hope that nations can move speedily to deliver proven and safe medical treatments to vulnerable populations without incurring undue, unnecessary and officious regulatory obstruction.

This would appear to be the visionary, drug free and health enhancing approach. As these concepts are more widely understood it is hoped that regulators and administrators will cooperate to mobilize international best medical practice on behalf of those with whose care they have been entrusted. I would invite the legislators of New Jersey to work with us on these issues of major cultural importance.

Yours Sincerely,

A. Stuart Reece, MBBS (Hons.), FRCS (Ed.), FRCS (Glas.), MD, FRACGP.
Family Physician, Highgate Hill Brisbane,
Senior Lecturer, Medical School, University of Queensland,
Fellow, Drug Watch International,
Fellow, Drug Free Australia,
Member, Society for Neuroscience,
Member, International Cannabinoid Research Society,
Attendee, College of the Problems of Drug Dependence Conferences 2002-2006.
Awardee, National Institute of Drug Abuse, International, 2003, 2004, 2006.

Motivational interviewing can yield excellent results and the basic skills and techniques are easy to learn. Dr Malcolm Thomas sets out the basics of promoting behaviour change

Helping patients or clients to change their behaviour can be frustrating. As professionals, we can get into a cycle of giving advice and making suggestions, only to feel that everything we suggest is being rejected. Specialist workers often have some training in more effective techniques – this article is aimed at frontline staff, most of whom will not have had such training.
There is now rather compelling evidence that the approach known as motivational interviewing produces better results than standard care (also called ‘business as usual’ or ‘finger wagging’). A full motivational interview takes between
45 and 60 minutes. The necessary training takes two, three or more days so it’s not surprising that this has been the preserve of specialists. However, the insights and techniques of motivational interviewing are available to ‘ordinary’ practitioners. I work for a training company and it’s our contention that everyone whose job includes counselling patients or clients regarding behaviour
change can enhance their professional effectiveness with some understanding, and judicious use, of relevant techniques.
Each of the following techniques takes no more than a few minutes to use and frontline practitioners can use them flexibly in relevant professional conversations. Regard the list as a toolkit from which the relevant tool can be unpacked as needed.

Many clients exhibit two or more behaviours that may profitably be changed, such as alcohol, drug use and diet. Usually it’s the professional who chooses which one to talk about, but allowing the client to choose the focus may enhance motivation. This can be achieved by running verbally through the options as the professional sees them and inviting the client to choose, such as:
‘It looks there are three things we could talk about today. Firstly your drug use, secondly your drinking and thirdly your diet. Does that sound right?’ Then, if the client agrees: ‘OK, so which would you like us to focus on today?’ People can be a bit vague about their habits. A typical answer to ‘how much alcohol do you drink’ is likely to be something like ‘Well, that’s a good question. It’s hard to say. Depends on this and that.’ It’s usually profitable to clarify what is going on at an early stage in your
professional relationship. A recommended technique is the ‘typical day’ question. For example, ‘I wonder if I could spend a couple of minutes learning more about your drinking? Can I ask you to talk me through a typical day, starting when you wake up
and finishing when you go to bed? Tell me where you go, what you do and where your drinking fits in.’ Variations on this include asking about a specific day (yesterday, last Saturday) or a typical week (which can be better for some behaviours). It’s normally very helpful to gauge the client’s readiness to change or consider changing. This may be apparent from things they have said and it certainly can emerge naturally from the conversation, but this is not always the case. While it’s rare for there to be no real clue, it can often be very unclear just how much readiness there is to change. It’s helpful to break readiness to change down into two components – importance and confidence. One strategy is to ask specifically about these in turn, using ‘scaling questions’. For example, ‘Can I just ask you a couple of questions? On a scale of one to ten, how important is it for you to cut down your drug use?’ Say the client responds with ‘Oh, I don’t know. Maybe around a three,’ your response could be ‘I see – thanks. Can I ask a similar question? On a scale of one to ten, if you decided to cut down, how confident would you be that you could make the change?’ Their response might be: ‘That’s a good question. Maybe six-ish. I cut down quite well for a while once. I think I could do that again.’

One advantage of this approach is that you can use it as a launch pad for further exploration, such as: ‘You told me you were at three or four for importance. So can I ask you why three and not one or two?’ ‘Well, it does sometimes get me into trouble. I’d like to think I had a bit more control over it and that it didn’t dominate my life quite so much.’ ‘Alright, so what would have to happen to move that score up to say five or six?’ ‘Well, if I got properly sick with it, I think that might do it.’ People aren’t daft. They indulge in unhealthy behaviours because there’s a payoff. Being overweight is a side effect of eating, which is usually pleasurable. Substance users get some sort of ‘high’ from their substance, or a relief from withdrawal effects if dependent. Behaviours have a social context and many people enjoy doing things with friends, whether smoking, drinking or injecting.
An axiom of motivational interviewing is that our client can see pros and cons to their behaviour. Rather than offering our professional opinion, we can help by allowing the client to bring these out into the open – and then feed it back to them: ‘Can I just try to understand a bit better? Can I ask you about the pros and cons of your marijuana use? First, what are the pros of smoking it from your point of view, the things you like about smoking marijuana? ‘Well, it relaxes me a bit, you know. And when I light up a joint with my mates, we have a good laugh. And to be honest, I prefer a smoke to a drink because you don’t
get the hangovers – you know what I mean?’ ‘Yes, I think I see that. Ok, what about the cons? The things you don’t like so much?’ ‘Well, it sometimes costs me quite a bit you know. And if I get really stoned, then I miss half the day, which isn’t right. And my girlfriend isn’t keen – I think she might not stand for it forever.’ ‘Can I recap then? You’re telling me that it relaxes you, that you do it with your mates and that you prefer it to alcohol. On the other hand, it can cost a lot, you sometimes miss half a day and your girlfriend doesn’t like it?’ ‘That’s about right, yeah.’ ‘Where does that leave you today?’ This can really help in our efficient use of interview time. The client response usually tells us if they are ready to go further and get involved in change talk – or alternatively it may be clear that it isn’t profitable to take things any further today.

At any point in the discussion, resistance may emerge. It is tempting to meet resistance with reasoned argument – pointing out all the scientific reasons on the side of a behaviour change. Unfortunately, this usually has the effect of stiffening resistance. For example, ‘You really need to lose weight you know.’ ‘I guess so.’ ‘I think you should go on a diet.’ ‘I can’t because…’ This is known as negative self-talk. It has been shown that an increase in the amount of negative self-talk in an interview is associated with a lower chance of behaviour change occurring. It seems prudent to avoid provoking such statements. For example, ‘I get the impression I may be pushing you a bit too far here. Shall we stop talking about this today?’ ‘No… It’s ok, go on. It’s just that this is difficult for me to get my head around.’ This is known as ‘rolling with resistance’. It can be a very effective tactic to
prevent the emergence of negative self-talk. It demands that professionals should be on the lookout for signs of resistance at pretty much any stage in a behaviour change discussion.

Most of us who work with clients develop a well-polished series of mini-lectures by way of explaining all the regular things that come up and need explaining. Unfortunately, these mini-lectures may not really be wanted. Or else, we may fail to address important questions on the mind of the client. A mini-seminar might be better. A useful way of looking at this is ‘elicit – provide – elicit’. Elicit any questions or information needs and provide answers or information in response. When it comes to action talk, it is better to provide a range of options to be chosen from. Finally, elicit a response – find out how your information has been received. An example: ‘Can I explain anything to you, answer any questions?’ ‘Well, have you got any information about how many units are in my various drinks. And what do you think I should do to cut down?’ ‘Ok. Let’s see. This leaflet is good for information about units. How does this look?’ ‘Very clear, actually. Can I have that?’ ‘Definitely – it’s for you to take away. Anything catch your eye?’ ‘Yes. Look at this about glasses of wine. I had no idea there were so many units.’ This approach can lead to more effective use of professional time, while again minimising the risk of negative self-talk developing. Motivational interviewing gives better results than ‘business as usual’ and many of the individual skills and techniques are easy enough to learn and can be used in routine conversations with patients or clients. I’ve outlined and demonstrated a range of the most useful
micro-skills, with examples of how they might fit into your conversations but a very readable and immensely practical textbook I’d recommend to any DDN reader is Health Behavior Change – a guide for practitioners by Stephen Rollnick, Chris Butler
and Pip Mason (Churchill Livingstone) – despite the spelling, it’s a British book.

Dr Malcolm Thomas is director of national training provider Effective Professional
Interactions Ltd. www.effectivepi.co.uk

Source: drinkanddrugsnews Jan 2010