Scientific and political challenges in North America's first randomized controlled trial of heroin-assisted treatment for severe heroin addiction: Rationale and design of the NAOMI study

Oviedo‐Joekes, Eugenia; Nosyk, Bohdan; Marsh, David C.; Guh, Daphne; Brissette, Suzanne; Gartry, Candice; Krausz, Michael; Anis, Aslam H.; Schechter, Martin T.

doi:10.1177/1740774509105222

Cited by 37 publications

(32 citation statements)

References 57 publications

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“…The main difference with other trials was the 12-month duration of HAT, which was introduced for legal and political reasons. The only other trial with a predetermined end of HAT was the Canadian study, in which street heroin use rose in the experimental group between the 9- and 12-month assessments [5,34]. In the Dutch trial, after 12 months, an interruption of HAT for 2 months also had a negative impact: 82% of the participants who were completers and responders deteriorated substantially [6].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Heroin-Assisted Treatment in Belgium: A Randomised Controlled Trial

et al. 2015

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Background/Aims: Heroin-assisted treatment (HAT) can improve the condition of heroin addicts still using street heroin after a methadone treatment. In Belgium, a new trial compared the efficacy of a HAT to existing methadone maintenance treatment. Methods: In this randomised controlled trial, HAT was limited to 12 months. Participants were assessed every 3 months. They were responders if they showed improvement on the level of street heroin use, health or criminal involvement. Results: 74 participants were randomised in the trial. The experimental group (n = 36) counted 30% of responders more than the control group (n = 38) at each assessment point (p < 0.05), except at 12 months where the difference (11%) was no longer significant (p = 0.35). Still, after 12 months, participants in the experimental group reported significantly greater improvements (p < 0.05) than the control group on the level of street heroin use and on the level of physical and mental health. Both groups reported significantly less criminal acts after 12 months (p < 0.001), but with no significant difference between the groups. Conclusions: This trial confirms the short-term efficacy of HAT for severe heroin addicts, who already failed methadone treatment.

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Section: Discussionmentioning

confidence: 99%

Efficacy of Heroin-Assisted Treatment in Belgium: A Randomised Controlled Trial

et al. 2015

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“…Detailed inclusion and exclusion criteria and baseline characteristics of the study participants have been published previously. 23,28 In brief, at baseline, the study participants were 25 years or older, with regular opioid injection, a minimum five-year history of opioid use, and at least two previous attempts at substitution treatment for opioid dependence. The average age of the participants was 39.7 years, and 61.4% were men.…”

Section: Model Designmentioning

confidence: 99%

“…The baseline prevalence of HIV infection was 9.6% and of hepatitis C virus infection 62.9%. 23 Health states in our model 29 included treatment (diacetylmorphine or methadone maintenance treatment), relapse (defined by opioid use outside of treatment), abstinence from opioids and death. Patients in the model belonged to one of two cohorts (diacetylmorphine or methadone maintenance treatment), and all patients entered the model in a treatment state, which was assumed to be their third attempt at treatment.…”

Section: Model Designmentioning

confidence: 99%

“…In addition to political challenges associated with the therapy, 23 there remains concern over the direct cost of diacetylmorphine over the long term, because it can be as much as 10 times greater than conventional methadone maintenance treatment. 21 The North American Opiate Medication Initiative was only one year in duration, but a policy to introduce diacetylmorphine might have both positive and negative longerterm implications.…”

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confidence: 99%

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Cost-effectiveness of diacetylmorphine versus methadone for chronic opioid dependence refractory to treatment

Nosyk

Guh

Bansback

et al. 2012

CMAJ

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115

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“…The North American Opiate Medication Initiative (NAOMI) trial in Canada showed heroin-assisted maintenance of "refractory" opioid dependence to have better outcomes compared to methadone treatment in terms of retention in treatment and clinical response [79,80]. An important caveat is that all those in the trial had previously failed methadone treatment, and so those randomized to methadone were, in effect, randomized to a treatment previously found ineffective.…”

Section: Other Pharmacotherapy Paradigmsmentioning

confidence: 99%

International Expansion of the Use of Pharmacotherapies for the Treatment of Opioid Dependence

Kresina¹

2012

Clinic Experiment Pharmacol

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Until recently, the global availability and consumption of opioid agonists and psychotropic medications have been below the levels needed for research to demonstrate local efficacy and to develop local evidence-based best medical practices. In addition, the global availability and use of opioid agonists and psychotropic medications have not been sufficient to implement the well documented efficacy shown for the treatment of opioid dependence that has been developed by research over the last 40 years. This strong research base has resulted in the development of evidencebased medical practices, such as Medication Assisted Treatment (MAT) for opioid dependence. The recognition of MAT as an effective medical treatment for opioid abuse and dependence has resulted in a substantial global increase in the medical use of opioid agonists and psychotropic medications to address opioid dependence. This increase is particularly evident in the initiation of new MAT programs in regions of Europe, North America, Africa, Asia and Oceania. While in other regions of the world, the medical use of opioid agonists and psychotropic medications have not substantially increased, the implementation of MAT programs have begun as part of the global effort to reduce HIV/AIDS. These HIV prevention programs have utilized MAT as an element of programs that target injection drug users to reduce their risk of both acquiring and transmitting HIV infection. Thus, this article documents the recent international expansion of the use of MAT for opioid dependence as a result of efforts to increase access and availability of evidence based treatments for opioid dependence as well as efforts to reduce the spread of infectious diseases, such as HIV/AIDS.

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Scientific and political challenges in North America's first randomized controlled trial of heroin-assisted treatment for severe heroin addiction: Rationale and design of the NAOMI study

Cited by 37 publications

References 57 publications

Efficacy of Heroin-Assisted Treatment in Belgium: A Randomised Controlled Trial

Efficacy of Heroin-Assisted Treatment in Belgium: A Randomised Controlled Trial

Cost-effectiveness of diacetylmorphine versus methadone for chronic opioid dependence refractory to treatment

International Expansion of the Use of Pharmacotherapies for the Treatment of Opioid Dependence

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