Heroin Assisted Treatment/Heroin Maintenance
Law and Policy
Sociopolitical and Clinical Research
North American Opiate Medication Initiative and Study to Assess Longer-term Opioid Medication Effectiveness (NAOMI and SALOME)
(Prescription Heroin and Heroin Maintenance)"Heroin prescription is a form of medical care that involves strictly regulated and controlled prescription of heroin. Offered on its own or as a complement to treatment programs, it is often targeted for use by people for whom opioid substitution treatment and other programs have not succeeded."
"Findings show such programs are feasible and are associated with a number of positive outcomes,12 including:
• helping people to stop or reduce their illegal drug use;13
• avoiding illness and death as a result of overdose by ensuring access to a drug of known quality and strength;14
• retention in medical care;15
• facilitating a gradual change from heroin to opioid substitution therapy;16
• reducing the risk of HIV and hepatitis resulting from unsafe injection practices;17 and
• promoting general health and well-being.18
• reducing crime related to the acquisition of drugs;19
• reducing the number or visibility of drug markets and public drug use;
• lowering costs associated with health care, social welfare, criminal justice and prisons;20 and
• promoting social integration, including with respect to employment, accommodation and family life.21"Source:Canadian HIV/AIDS Legal Network, "Legislating on Health and Human Rights: Model Law on Drug Use and HIV/AIDS Module 8: Heroin prescription programs," (Toronto, Ontario: 2006), pp. 7-8.
(Proof of Efficacy of Heroin-Assisted Treatment) "Over the past 15 years, six RCTs [Randomized Controlled Trials] have been conducted involving more than 1,500 patients, and they provide strong evidence, both individually and collectively, in support of the efficacy of treatment with fully supervised self-administered injectable heroin, when compared with oral MMT, for long-term refractory heroin-dependent individuals. These have been conducted in six countries: Switzerland (Perneger et al., 1998); the Netherlands (van den Brink et al., 2003); Spain (March et al., 2006); Germany (Haasen et al., 2007), Canada (Oviedo-Joekes et al., 2009) and England (Strang et al., 2010).
"Across the trials, major reductions in the continued use of ‘street’ heroin occurred in those receiving SIH [Supervised Injectable Heroin] compared with control groups (most often receiving active MMT). These reductions occasionally included complete cessation of ‘street’ heroin use, although more frequently there was continued but reduced irregular use of ‘street’ heroin, at least through the trial period (ranging from 6 to 12 months). Reductions also occurred, but to a lesser extent, with the use of a range of other drugs, such as cocaine and alcohol. However, the difference between reductions in the SIH group and the various control groups was not as great (compared with major reductions in the use of ‘street’ heroin)."Source:European Monitoring Centre for Drugs and Drug Addiction, "EMCDDA INSIGHTS No. 11: New heroin-assisted treatment: Recent evidence and current practices of supervised injectable heroin treatment in Europe and beyond" (Luxembourg: Publications Office of the European Union, April 2012), doi: 10.2810/50141, p. 11.
(Effectiveness of Heroin-Assisted Treatment) "Heroin prescription represents a contentious approach to treatment. Many would question whether giving users the drug that they are addicted to constitutes 'treatment' in the normal sense of the word. As with any form of substitution therapy, there is also the question of whether users can be moved on from their drug use – perhaps the fact that users are being prescribed their drug of choice (rather than a frequently unpopular alternative) may mean that users will find it even more difficult to move on to abstinence. There is insufficient evidence to answer this latter concern. However, what the evidence base does indicate is that, in the short term, heroin prescription appears to be an effective way to retain users in treatment who have a history of failing in other treatment settings, with consequent benefits in terms of reduced drug use, crime and social reintegration."Source:Lloyd, Charlie and McKeganey, Neil, "Drugs Research: An overview of evidence and questions for policy," Joseph Rowntree Foundation (London, United Kingdom: June 2010), p. 50.
(Medication-Based Treatment for Opioid Dependence) "Medication-based treatment for opioid dependence consists of 2 distinct approaches: detoxification and maintenance.4 Detoxification involves the use of medications to bring a patient from an opioid-dependent to an opioid-free state. The medications used are designed to decrease withdrawal-related discomfort and complications. Maintenance therapy involves the substitution of an abused opioid such as heroin or narcotic analgesics, which are often used intravenously or intranasally several times a day, by a medically prescribed opioid such as methadone or buprenorphine that can be taken orally and administered once a day in combination with counseling."Source:O'Connor, Patrick G., "Methods of Detoxification and Their Role in Treating Patients With Opioid Dependence," Journal of the American Medical Association (Chicago, IL: American Medical Association, August 24, 2005), Vol. 294, No. 8, p. 961.
(Effectiveness of Heroin-Assisted Treatment Compared With Methadone Maintenance) "Our results on the cost-effectiveness of diacetylmorphine are consistent with those of an economic analysis based on data from two Dutch heroin-assisted treatment trials,21 despite differences in the design of the Dutch trials and the North American Opiate Medication Initiative, and the time horizon and analytic design of the economic analyses.
"The Dutch trials compared methadone maintenance treatment with a combination of methadone and diacetylmorphine (prescribed concurrently), which changed the profiles of health utility and health resource use. Furthermore, participants in the Dutch trials were recruited from methadone maintenance programs, whereas participants in the North American Opiate Medication Initiative had to have been out of treatment for at least six months before trial entry. We considered a range of time horizons, using external parameters where necessary to extrapolate results to longer time horizons. The other economic analysis used trial data exclusively and focused only on a 12-month study period. The consistency in results between our analysis and the analysis of the Dutch trials appears to be due primarily to the advantages diacetylmorphine provides in retaining individuals in treatment.
"We believe a lifetime horizon is the most appropriate period for evaluating treatments of chronic, recurrent diseases such as opioid dependence, because treatment is available indefinitely in practice and will have a long-term impact. The key outcomes, such as progressing to a drug-free state or death, would likely not be realized within the 12-month period of the North American Opiate Medication Initiative."Source:Bohdan Nosyk PhD., et al., "Cost-effectiveness of diacetylmorphine versus methadone for chronic opioid dependence refractory to treatment," Canadian Medical Association Journal, April 3, 2012, 184(6):E317-E328.
(Comparison of Client Satisfaction Between Those Treated With Oral Methadone Versus Injectable Heroin) "The present study determined participants’ satisfaction with received treatments in the first North American RCT [Randomized Controlled Trial] to provide injectable diacetylmorphine or hydromorphone compared to oral methadone for the treatment of long-term, treatment resistant, opioiddependency. At 3 and 12 months, participants were satisfied with the treatment received during the study period, although satisfaction was greater for those randomized to receive injectable treatments. At 3 months, participants who reported that the program met their needs were more likely to be retained at 12 months. To our knowledge this is the first study to assess treatment satisfaction among participants receiving supervised injectable diacetylmorphine or hydromorphone.
"Regardless of the outcome of the randomization, participants in the trial were highly satisfied with the treatment received. This follows previous studies which have consistently found that patients tend to report high levels of treatment satisfaction, including community health services , services for mental health , addiction , and opioid dependence ."Source:Marchand et al., "Client satisfaction among participants in a randomized trial comparing oral methadone and injectable diacetylmorphine for long-term opioid-dependency," BMC Health Services Research, 2011, 11:174.
(Comparison of Client Satisfaction Between Those Treated for Opioid Dependence With Oral Methadone Versus Injectable Heroin) "Among long-term chronic opioid injectors participating in a randomized clinical trial prescribing injectable diacetylmorphine or hydromorphone and oral methadone, those receiving injectable medications were more satisfied with treatment. Independent of treatment group, treatment satisfaction was also an indicator of retention in treatment, as well as treatment response, including a reduction in substance use. As the first study in North America to provide injectable OST, these findings have valuable implications for future RCTs, which should continue to measure satisfaction in order to identify areas of improvement. These findings also provide evidence-based knowledge for good clinical practice guidelines in the treatment of chronic opioid dependence in Canada as they highlight the association between treatment satisfaction and improved treatment outcomes, particularly for those receiving more innovative treatment medications."Source:Marchand et al., "Client satisfaction among participants in a randomized trial comparing oral methadone and injectable diacetylmorphine for long-term opioid-dependency," BMC Health Services Research, 2011, 11:174.
(Heroin-Assisted Treatment) "Uniquely in the United Kingdom, methadone ampoules can also be prescribed. Historically, they have at times been a substantial part of opiate substitution treatment in the United Kingdom (e.g. around 30% in the 1970s and approximately 10% in the early 1990s), but they now account for approximately 2% of all methadone prescriptions in England and Wales (Strang et al., 2007). Injectable heroin can also be prescribed in the United Kingdom to heroin addicts as an opiate treatment and has been a treatment option for over 80 years, and this has historically been important. However, over the last 30 years, this practice has become progressively rarer and now comprises less than 1% of all opiate substitution treatment in the United Kingdom. The established method of heroin prescription in the United Kingdom has been as a ‘take-away’ supply, which is then injected in an unsupervised context. In practice, few doctors have prescribed it and few patients have received it (Metrebian et al., 2002)."Source:European Monitoring Centre for Drugs and Drug Addiction, "EMCDDA INSIGHTS No. 11: New heroin-assisted treatment: Recent evidence and current practices of supervised injectable heroin treatment in Europe and beyond" (Luxembourg: Publications Office of the European Union, April 2012), doi: 10.2810/50141, pp. 134-135.
Laws and Policies
(International Drug Conventions and Heroin-Assisted Treatment) "Many countries believe (erroneously) that the international drug conventions prohibit the use of heroin in medical treatment. Furthermore, the International Narcotics Control Board (INCB) has exerted great pressure on countries to cease prescribing heroin for any medical purpose. Nevertheless, a few countries, including the UK, Belgium, the Netherlands, Iceland, Malta, Canada and Switzerland, continue to use heroin (diamorphine) for general medical purposes, mostly in hospital settings (usually for severe pain relief). Until recently, however, Britain was the only country that allowed doctors to prescribe heroin for the treatment of drug dependence."Source:Stimson, Gerry V., and Nicky Metrebian, Centre for Research on Drugs and Health Behavior, "Prescribing Heroin: What is the Evidence?" (London, England: Rowntree Foundation, 2003), p. 4.
(Safe Injection Sites and International Drug Control Treaties) "23. It might be claimed that this approach [drug injection rooms] is incompatible with the obligations to prevent the abuse of drugs, derived from article 38 of the 1961 Convention and article 20 of the 1971 Convention. It should not be forgotten, however, that the same provisions create an obligation to treat, rehabilitate and reintegrate drug addicts, whose implementation depends largely on the interpretation by the Parties of the terms in question. If, for example, the purpose of treatment is not only to cure a pathology, but also to reduce the suffering associated with it (like in severe-pain management), then reducing IV drug abusers exposure to pathogen agents often associated with their abuse patterns (like those causing HIV-AIDS, or hepatitis B) should perhaps be considered as treatment. In this light, even supplying a drug addict with the drug he depends on could be seen as a sort of rehabilitation and social reintegration, assuming that once his drug requirements are taken care of, he will not need to involve himself in criminal activities to finance his dependence."Source:"Flexibility of Treaty Provisions as Regards Harm Reduction Approaches," Legal Affairs Section UNDCP (Vienna, Austria: International Narcotics Control Board, September 30, 2002), p. 5.
(Human Rights and Heroin-Assisted Treatment) "Heroin prescription is consistent with a number of state responsibilities under international human rights instruments. The Universal Declaration of Human Rights states that 'everyone has the right to a standard of living adequate for the health and wellbeing of himself … including … medical care and necessary social services.'24 Similarly, the International Convention on Economic, Social and Cultural Rights (ICESCR) recognizes the 'right of everyone to the highest attainable standard of physical and mental health.'25 The UNAIDS/OHCHR International Guidelines on HIV/AIDS and Human Rights recommend that states ensure the 'widespread availability of qualitative prevention measures and services, adequate HIV prevention and care information' in order to protect the human rights of people living with HIV/AIDS and stem the spread of the virus." [Note: Ellipses used in source document.]Source:Canadian HIV/AIDS Legal Network, "Legislating on Health and Human Rights: Model Law on Drug Use and HIV/AIDS Module 8: Heroin prescription programs," (Tornoto, Ontario: 2006), p. 9.
(Political Opposition to Heroin-Assisted Treatment) "The existing interference and non-evidence-based opposition from politicians and care providers, who refuse to acknowledge the limitations of methadone maintenance and the superiority of prescribed heroin in selected populations, is arguably unethical. Denying effective second-line therapy to those in need ultimately serves to condemn many users of illicit heroin to the all too common outcomes of untreated heroin addiction, including HIV infection or death from overdose."Source:Kerr, Thomas; Montaner, Julio SG; and Wood, Evan, "Science and politics of heroin prescription," The Lancet (London, United Kingdom:May 29, 2010) Vol. 375, Issue 9729, p. 1850.
(History of Heroin-Assisted Treatment) "The emerging consensus is that heroin is a treatment for a limited number of illicit-drug users who do not do well with other medicines. Historically, however, heroin was the main 'drug of choice' for treatment. In the 1920s and earlier in Britain, it was the treatment or maintenance drug for compliant middle-class addicts, those who accepted the authority of the doctor to prescribe to them. The prescription of heroin was the basis of the so-called British system, which operated until the 1960s.6 This was not the case in the United States. The inability to conduct the NAOMI trial in the United States reflects a historically different attitude toward the medical prescription of heroin to addicts; this prohibition dates back to the implementation of the 1914 Harrison Narcotics Act before World War I. Doctors were prosecuted thereafter if they prescribed heroin for addicts."Source:Berridge, Virginia, "Heroin Prescription and History," New England Journal of Medicine (Boston, MA: Massachusetts Medical Society, August 20, 2009) Volu. 361, Issue 8, p. 820.
(Research Ethics) "The most widely accepted document outlining ethical standards for research at the international level is the Declaration of Helsinki . There is a crucial section, paragraph 30, of the document that is pertinent to research on heroin treatment for addiction. It reads:
"'At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study'
"The main motive for this portion of the international research guidelines is to prevent the sponsors of research trials (government, university, hospital or private) and physician collaborators from initiating research on subjects who would otherwise be unable to access the treatment offered in the research and then taking away the treatment when the research schedule is complete ."Source:Small, Dan, and Drucker, Ernest, "Policy Makers Ignoring Science Scientists Ignoring Policy: The Medical Ethical Challenges of Heroin Treatment," Harm Reduction Journal (London, United Kingdom: May 2006), Vol. 3, p. 13.
Sociopolitical and Clinical Research
(Heroin-Assisted Treatment vs. Methadone Maintenance) "The central result of the German model project shows a significant superiority of heroin over methadone treatment for both primary outcome measures. Heroin treatment has significantly higher response rates both in the field of health and the reduction of illicit drug use. According to the study protocol, evidence of the greater efficacy of heroin treatment compared to methadone maintenance treatment has thus been produced. Heroin treatment is also clearly superior to methadone treatment when focusing on patients, who fulfill the two primary outcome measures."Source:Naber, Dieter, and Haasen, Christian, Centre for Interdisciplinary Addiction Research of Hamburg University, "The German Model Project for Heroin Assisted Treatment of Opioid Dependent Patients -- A Multi-Centre, Randomised, Controlled Treatment Study: Clinical Study Report of the First Study Phase," January 2006, p. 117.
(Crime Reduction) "Overall, results indicate that heroin prescription is a very promising approach in reducing any type of drug related crime across all relevant groups analyzed. It affects property crime as well as drug dealing and even use/possession of drugs other than heroin. These results suggest that heroin maintenance does not only have an impact by reducing the acquisitive pressure of treated patients, but also seems to have a broader effect on their entire life-style by stabilizing their daily routine through the commitment to attend the prescription center twice or three times a day, by giving them the opportunity for psychosocial support, and by keeping them away from open drug scenes."Source:Ribeaud, Denis, "Long-term Impacts of the Swiss Heroin Prescription Trials on Crime of Treated Heroin Users," Journal of Drug Issues (Talahassee, FL: University of Florida, Winter 2004), p. 188.
(Heroin-Assisted Treatment vs Methadone Maintenance) "To conclude, it must be stated that heroin treatment involves a somewhat higher safety risk than methadone treatment. This is mainly due to the intravenous form of application. The rather frequently occurring respiratory depressions and cerebral convulsions are not unexpected and can easily be clinically controlled. Overall, the mortality rate was low during the first study phase, and no death occurred with a causal relationship with the study medication. Compared to much higher health risks related to the i.v. application of street heroin, the safety risk of medically controlled heroin prescription has to be considered as low."Source:Naber, Dieter, and Haasen, Christian, Centre for Interdisciplinary Addiction Research of Hamburg University, "The German Model Project for Heroin Assisted Treatment of Opioid Dependent Patients -- A Multi-Centre, Randomised, Controlled Treatment Study: Clinical Study Report of the First Study Phase," January 2006, p. 150.
(Decline in Incidence of Heroin Use) "The incidence of regular heroin use in the canton of Zurich started with about 80 new users in 1975, increased to 850 in 1990, and declined to 150 in 2002, and was thus reduced by 82%. Incidence peaked in 1990 at a similar high level to that ever reported in New South Wales, Australia, or in Italy. But only in Zurich has a decline by a factor of four in the number of new users of heroin been observed within a decade. This decline in incidence probably pertains to the whole of Switzerland because the number of patients in substitution treatment is stable, the age of the substituted population is rising, the mortality caused by drugs is declining, and confiscation of heroin is falling. Furthermore, incidence trends did not differ between urban and rural regions of Zurich. This finding is suggestive of a more similar spatial dynamic of heroin use for Switzerland than for other countries."Source:Nordt, Carlos, and Rudolf Stohler, "Incidence of Heroin Use in Zurich, Switzerland: A Treatment Case Register Analysis," The Lancet, Vol. 367, June 3, 2006, p. 1833.
(Prescription Injectable Opiates) "Prescribing injectable opiates is one of many options in a range of treatments for opiate-dependent drug users. In showing that it attracts and retains long term resistant opiate-dependent drug users in treatment and that it is associated with significant and sustained reductions in drug use and improvements in health and social status, our findings endorse the view that it is a feasible option."Source:Metrebian, Nicky, Shanahan, William, Wells, Brian, and Stimson, Gerry, "Feasibility of prescribing injectable heroin and methadone to opiate-dependent drug users; associated health gains and harm reductions," The Medical Journal of Australia (Sydney, Australia: June 1998) Volume 168, Issue 12, pp. 596-600.
(Reduction in Heroin Use) "We have shown that treatment with supervised injectable heroin leads to significantly lower use of street heroin than does supervised injectable methadone or optimised oral methadone. Furthermore, this difference was evident within the first 6 weeks of treatment.
"This randomised controlled trial of treatment with supervised injectable opiates builds on the findings of five randomised trials of supervised injectable heroin versus oral methadone."Source:Strang, John; Metrebian, Nicola; Lintzeris, Nicholas; Potts, Laura; Carnwath, Tom; Mayet, Soraya; Williams, Hugh; Zador, Deborah; Evers, Richard; Groshkova, Teodor; Charles, Vikki; Martin, Anthea; and Forzisi, Luciana, "Supervised injectable heroin or injectable methadone versus optimised oral methadone as treatment for chronic heroin addicts in England after persistent failure in orthodox treatment (RIOTT): a randomised trial," The Lancet (London, United Kingdom: May 29, 2010) Vol. 375, Issue 9729, p.
(Retention in Treatment) "These pilot study findings showed that opiate-dependent injecting drug users with long injecting careers (most started between 1970 and 1982) and for whom opiate treatment had failed multiple times previously were attracted into and retained by therapy with injectable opiates."Source:Metrebian, Nicky, Shanahan, William, Wells, Brian, and Stimson, Gerry, "Feasibility of prescribing injectable heroin and methadone to opiate-dependent drug users; associated health gains and harm reductions," The Medical Journal of Australia (MJA 1998; 168: 596-600).
- Source:Ribeaud, Denis, "Long-term Impacts of the Swiss Heroin Prescription Trials on Crime of Treated Heroin Users," Journal of Drug Issues (Talahassee, FL: University of Florida, Winter 2004), p. 188.
(Heroin Assisted Treatment vs Methadone Maintenance) "The German model project for heroin-assisted treatment of opioid dependent patients is so far the largest randomised control group study that investigated the effects of heroin treatment. This fact alone lends particular importance to the results in the (meanwhile worldwide) discussion of effects and benefits of heroin treatment. For the group of so-called most severely dependent patients, heroin treatment proves to be superior to the goals of methadone maintenance based on pharmacological maintenance treatment. This result should not be left without consequences. In accordance with the research results from other countries, it has to be investigated to what extent heroin-assisted treatment can be integrated into the regular treatment offers for severely ill i.v. opioid addicts."Source:Naber, Dieter, and Haasen, Christian, Centre for Interdisciplinary Addiction Research of Hamburg University, "The German Model Project for Heroin Assisted Treatment of Opioid Dependent Patients -- A Multi-Centre, Randomised, Controlled Treatment Study: Clinical Study Report of the First Study Phase," January 2006, p. 122.
Swiss Heroin Maintenance
(Heroin Assisted Treatment Trials) "Based on its 1992 call for proposals, the Federal Office of Public Health authorized HAT trials in Zürich, Bern, Basel, and Geneva involving about 1,000 persons in the first instance (Bammer et al. 2003). Studies of HAT continued in Switzerland beyond the first trials. The full results of this work are beyond the scope of this paper, but what may be hundreds of peer-reviewed journal articles on the trials, as well as a book produced by FOPH (Rihs-Middel et al. 2005), attest to the care taken to document a wide range of health and social outcomes from the HAT experience. In brief, some of these results are as follows (See esp. Uchtenhagen 2009, 34 and Bammer et al. 2003, 365):
" It was possible to stabilize dosages of heroin, usually in two or three months, without a continuing increase of dosages, which some had feared.
" There was significant and measurable improvement in health outcomes for patients, including significantly reduced consumption of illicit heroin and even illicit cocaine.
" There was a significant reduction in criminal acts among the patients, to the point where the estimated benefits of this effect well exceeded the cost of the treatment (See also Killias et al. 2005).
" Heroin from the trials did not find its way into illicit markets.
" Initiation of new heroin use did not increase.
" Utilization of treatments other than HAT, especially methadone, increased after the advent of HAT rather than declining as some had feared.
In short, the fears of opponents of HAT were largely refuted by solid evidence, though, of course, political debate would continue."Source:Csete, Joanne, "From the Mountaintops: What the World Can Learn from Drug Policy Change in Switzerland," Global Drug Policy Program (New York, NY: Open Society Foundations, May 2010), p. 19.
(Swiss Heroin-Assisted Treatment) "It has emerged that heroin-assisted treatment is a suitable option only for a small proportion (currently 4%) of the 30,000 severely dependent injecting drug users. Heroin-assisted treatment is not a replacement for other substitution or abstinence-based therapies, but an important addition for those drug users that have so far fallen through the therapeutic net. This is confirmed by the relatively modest increase in patient numbers since the bar on the legally permitted maximum number was lifted."Source:"Heroin-Assisted Treatment (HeGeBe) in 2000," Swiss Federal Office of Public Health (Bern, Switzerland: SFOPH, August 28, 2001), p. 2.
(Treatment Description) "Despite the availability of a wide range of treatment programs, including methadone substitution, not all drug addicts with serious health and social problems could be motivated to enter treatment. A core group remained, which was characterized by numerous social and physical deficiencies. In an attempt to reach this group, Heroin on prescription was launched in 1994 as part of a nationally-based research project. Admission criteria were a minimum age of 20 years, at least a two-year duration of daily intravenous heroin consumption, a negative outcome of at least two previous treatments, and documented social and health deficits as a consequence of their heroin dependence. The treatment consisted of between one to three injections of heroin a day, and medical, psychiatric, and social monitoring.
"After three years, the results showed, amongst numerous other findings, that:
" The program is able, to a greater extent than other treatments, to reach its designated target group.
" The improvements in physical health proved to be stable over the whole period.
" Illicit heroin and cocaine use regressed rapidly and markedly, whereas benzodiazepine use decreased only slowly and alcohol and cannabis consumption hardly declined at all.
" The participants' housing situation and fitness for work improved considerably.
" The income from illegal and semi-illegal activities decreased dramatically (10% as opposed to 69% originally).
" Both the number of offenders and the number of criminal offenses decreased by about 60% during the first six months of treatment."Source:van der Linde, Francois, "Moving Beyond the 'War on Drugs': The Swiss Drug Policy," James A. Baker III Institute for Public Policy (Houston, Texas: Rice University, April 11, 2002), p. 4.
(Medicalization of Heroin) "The harm reduction policy of Switzerland and its emphasis on the medicalisation of the heroin problem seems to have contributed to the image of heroin as unattractive for young people."Source:Nordt, Carlos, and Rudolf Stohler, "Incidence of Heroin Use in Zurich, Switzerland: A Treatment Case Register Analysis," The Lancet, Vol. 367, June 3, 2006, p. 1830.
(Decline in Problematic Heroin Use) "Heroin misuse in Switzerland was characterised by a substantial decline in heroin incidence and by heroin users entering substitution treatment after a short time, but with a low cessation rate. There are different explanations for the sharp decline in incidence of problematic heroin use. According to Ditton and Frischer, such a steep decline in incidence of heroin use is caused by the quick slow down of the number of non-using friends who are prepared to become users in friendship chains. Musto's generational theory regards the decline in incidence more as a social learning effect whereby the next generation will not use heroin because they have seen the former generation go from pleasant early experiences to devastating circumstances for addicts, families, and communities later on."Source:Nordt, Carlos, and Rudolf Stohler, "Incidence of Heroin Use in Zurich, Switzerland: A Treatment Case Register Analysis," The Lancet, Vol. 367, June 3, 2006, p. 1833.
(Crime Reduction) "With respect to the group of those treated uninterruptedly during four years, a strong decrease in the incidence and prevalence rates of overall criminal implication for both intense and moderate offenders was found. As to the type of offense, similar diminutions were observed for all types of offenses related to the use or acquisition of drugs. Not surprisingly, the most pronounced drop was found for use/possession of heroin. In accordance with self-reported and clinical data (Blaettler, Dobler-Mikola, Steffen, & Uchtenhagen, 2002; Uchtenhagen et al., 1999), the analysis of police records suggests that program participants also tend strongly to reduce cocaine and cannabis use probably because program participants dramatically reduced their contacts with the drug scene when entering the program (Uchtenhagen et al., 1999) and were thus less exposed to opportunities to buy drugs. Consequently, their need for money is not only reduced with regard to heroin but also to other substances. Accordingly, the drop in acquisitive crime, such as drug selling or property crime, is also remarkable and related to all kinds of thefts like shoplifting, vehicle theft, burglary, etc. Detailed analyses indicated that the drop found is related to a true diminution in criminal activity rather than a more lenient recording practice of police officers towards program participants.
"On average, males had higher overall rates than females in the pretreatment period. However, no marked gender differences were found with regard to in-treatment rates. Taken as a whole, this suggests that the treatment had a somewhat more beneficial effect on men than women. This result is corroborated by self-report data (Killias et al., 2002). With respect to age and cocaine use, no relevant in-treatment differences were observed. As to program dropout, after one year, about a quarter of the patients had left the program, and after four years, about 50% had left. Considering the high-risk profile of the treated addicts, this retention rate is, at least, promising."Source:Ribeaud, Denis, "Long-term Impacts of the Swiss Heroin Prescription Trials on Crime of Treated Heroin Users," Journal of Drug Issues (Talahassee, FL: University of Florida, Winter 2004), p. 187.
(Reasons for Discontinuing Treatment) "Finally, the analysis of the reasons for interrupting treatment revealed that, even in the group of those treated for less than one year, the majority did not actually drop out of the program but rather changed the type of treatment, mostly either methadone maintenance or abstinence treatment. Knowing that methadone maintenance treatment and a fortiori abstinence treatment is able to substantially reduce acquisitive crime, the redirection of heroin maintenance patients toward alternative treatments is probably the main cause for the ongoing reduction or at least stabilization of criminal involvement of most patients after treatment interruption. Thus the principal post-treatment benefit of heroin maintenance seems to be its ability to redirect even briefly treated high-risk patients towards alternative treatments rather than back 'on the street'."Source:Ribeaud, Denis, "Long-term Impacts of the Swiss Heroin Prescription Trials on Crime of Treated Heroin Users," Journal of Drug Issues (Talahassee, FL: University of Florida, Winter 2004), p. 188.
(Target Population) "As one of the responses to dramatically increasing drug scenes, heroin maintenance trials were implemented in Switzerland from 1994 onwards. The target population for this new treatment consists of heroin users who did not comply with other forms of treatment and who presented serious health and/or social problems."Source:Ribeaud, Denis, "Long-term Impacts of the Swiss Heroin Prescription Trials on Crime of Treated Heroin Users," Journal of Drug Issues (Talahassee, FL: University of Florida, Winter 2004), pp. 186-187.
"On average, males had higher overall rates than females in the pretreatment period. However, no marked gender differences were found with regard to intreatment rates. Taken as a whole, this suggests that the treatment had a somewhat more beneficial effect on men than women. This result is corroborated by selfreport data (Killias et al., 2002). With respect to age and cocaine use, no relevant in-treatment differences were observed. As to program dropout, after one year, about a quarter of the patients had left the program, and after four years, about 50% had left. Considering the high-risk profile of the treated addicts, this retention rate is, at least, promising."Source:Ribeaud, Denis, "Long-term Impacts of the Swiss Heroin Prescription Trials on Crime of Treated Heroin Users," Journal of Drug Issues (Talahassee, FL: University of Florida, Winter 2004), p. 187.
North American Opiate Medication Initiative (NAOMI)
"The North American Opiate Medication Initiative (NAOMI) is a carefully controlled (clinical trial) that will test whether medically prescribed heroin can successfully attract and retain street-heroin users who have not benefited from previous repeated attempts at methadone maintenance and abstinence programs.
"The NAOMI study will enroll 470 participants at three sites in Vancouver, Montreal and Toronto. The Toronto and Montreal sites are expected to begin recruitment this spring.
"Each site will enroll about 157 participants. About half of these volunteers will be assigned to receive pharmaceutical-grade heroin (the experimental group) and half will receive methadone (the control group). The prescribed heroin will be self-administered under careful medical supervision within a specially designed clinic. Those in the heroin group will be treated for 12 months then transitioned, over three months, into either methadone-maintenance therapy or another treatment program. The researchers expect a 6-9 month recruitment period, so that the total time to complete the study will be 21 to 24 months."
What is the NAOMI clinical trial?
"The North American Opiate Medication Initiative (NAOMI) was a randomized trial aimed at testing whether medically prescribed diacetylmorphine, the active ingredient in heroin, offered benefits over and above optimized methadone therapy in the treatment of individuals with chronic opioid dependence who were not benefiting from other available treatments. Patients allocated to injectable diacetylmorphine were more likely to stay in treatment and more likely to reduce their use of illegal drugs and other illegal activities than patients allocated to oral methadone.
If the NAOMI trial was a success, why the treatment did not continue?
"The NAOMI investigators requested permission to prescribe diacetylmorphine under compassionate use through Health Canada's Special Access Programme. However, the requests were denied. Also, the funding for both clinics (Vancouver and Montreal) was part of a CIHR grant that ended with the study period. The investigators are working on other options, such as the SALOME study. Canada is the only country where diacetylmorphine has been tested for addiction treatment and has been denied compassionate use."
"1. Heroin-assisted therapy proved to be a safe and highly effective treatment for people with chronic, treatment-refractory heroin addiction. Marked improvements were observed including decreased use of illicit “street” heroin, decreased criminal activity, decreased money spent on drugs, and improved physical and psychological health.
"2. The NAOMI trial attracted the most chronic and marginalized heroin users who were outside the treatment system and continued to use heroin despite numerous previous treatment attempts. Both heroin-assisted therapy and optimized methadone maintenance treatment achieved high retention rates and remarkable response rates in this difficult-to-treat group.
"3. Contrary to pre-existing concerns, the treatment clinics appeared to have no negative impacts on the surrounding neighbourhoods.
"4. Participants on hydromorphone did not distinguish this drug from heroin. Moreover, hydromorphone appeared to be equally effective as heroin although the study was not designed to test this conclusively. If this were proven to be true, hydromorphone-assisted therapy could offer legal, political and logistical advantages over heroin and could be made more widely available."Source:"Reaching the Hardest to Reach–Treating the Hardest-to-Treat," The NAOMI Study Team (Ottawa, Ontario: Canadian Institutes of Health, October 17, 2008), pp. 2 and 18.
(Findings from the North American Opiate Medication Initiative) "Our study had two primary findings. First, we found that most study participants were motivated for treatment, despite not accessing it in at least the past 6 months (as per trial entry criteria). This may be the result of a lack of accessible or attractive treatment options available to them. Second, we found that baseline motivation for treatment did not predict retention in either HAT [heroin assisted treatment] or MMT [methadone maintenance treatment], however motivated patients receiving HAT were more likely to achieve response than unmotivated patients. While HAT is likely to retain patients regardless of motivational status, success in treatment, in terms of decreases in illicit drug use and crime, is more likely among motivated patients, as measured in our study. Further, HAT was statistically significantly more effective than MMT on each of the outcomes assessed."Source:Nosyk, Bohdan; Geller, Josie; Guh, Daphne P.; Oviedo-Joekes, Eugenia; Brissette, Suzanne; Marsh, David C.; Schechter, Martin T.; Anis, Aslam H., "The effect of motivational status on treatment outcome in the North American Opiate Medication Initiative (NAOMI) study," Drug and Alcohol Dependence (Philadelphia, PA: College on Problems of Drug Dependence, September 2010), pp. 3-4.
(Comparison of Effectiveness of HAT and MMT, by Gender) "The present study investigated treatment response and retention by gender in North America’s first randomized controlled trial of injectable diacetylmorphine [DAM]. DAM showed greater effectiveness than MMT with respect to treatment retention and response at 12 months for both men and women, although there were significant treatment differences in more sub-scores for men than women. There were no gender differences in overall clinical response and retention at 12 months in the DAM and MMT groups."Source:Oviedo-Joekesa, Eugenia; Guh, Daphne; Brissette, Suzanne; Marchand, Kirsten; Marsh, David; Chettiarb, Jill; Nosyk, Bohdan; Krausz, Michael; Anisa, Aslam; Schechtera, Martin T., "Effectiveness of diacetylmorphine versus methadone for the treatment of opioid dependence in women," Drug and Alcohol Dependence, (Philadelphia, PA: College on Problems of Drug Dependence, September 2010), p. 4.
Study to Assess Longer-Term Opioid Medication Effectiveness (SALOME)
"What is the SALOME clinical trial?
"The Study to Assess Longer-term Opioid Medication Effectiveness [SALOME] is a clinical trial that will test whether diacetylmorphine, the active ingredient of heroin, is as good as hydromorphone (Dilaudid®), a licensed medication, in benefiting people suffering from chronic opioid addiction who are not benefiting sufficiently from other treatments. Also, this study will test if those effectively treated with injectable diacetylmorphine or hydromorphone can be successfully switched and retained to the oral formulations of the medications."
"How are SALOME and NAOMI trials related?
"In the NAOMI study, a small group of patients received hydromorphone (Dilaudid®) instead of diacetylmorphine in a double-blind basis (nor the patients or staff knew which drug they were receiving), for the purpose of validation of self-reported use of street heroin in urine toxicological tests. An unexpected finding was that injection patients could not accurately discriminate whether they were receiving diacetylmorphine or hydromorphone."