Trial reportClinical trials (London, England)2009
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.
Trial report in Clinical trials (London, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed.
- Differential long-term outcomes for voluntary and involuntary transition from injection to oral opioid maintenance treatment.Substance abuse treatment, prevention, and policy · 2014Trial
- Client satisfaction among participants in a randomized trial comparing oral methadone and injectable diacetylmorphine for long-term opioid-dependency.BMC health services research · 2011Trial
- Characteristics and response to treatment among Aboriginal people receiving heroin-assisted treatment.Canadian journal of public health = Revue canadienne de sante publiqueTrial
- The Impact of Stigma on People with Opioid Use Disorder, Opioid Treatment, and Policy.Substance abuse and rehabilitation · 2022Review
- New Approaches in Drug Dependence: Opioids.Current addiction reports · 2021Review
- Trust in research physicians as a key dimension of randomized controlled trial participation in clinical addictions research.Substance abuse · 2021Article
- The political and scientific challenges in evaluating compulsory drug treatment centers in Southeast Asia.Harm reduction journal · 2017Article
- A chance to stop and breathe: participants' experiences in the North American Opiate Medication Initiative clinical trial.Addiction science & clinical practice · 2014Article
- The cost of providing methadone maintenance treatment in Ontario, Canada.The American journal of drug and alcohol abuse · 2012Article
- Cost-effectiveness of diacetylmorphine versus methadone for chronic opioid dependence refractory to treatment.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2012Article
- Sex work involvement among women with long-term opioid injection drug dependence who enter opioid agonist treatment.Harm reduction journal · 2012Article
- Negotiating the Relationship Between Addiction, Ethics, and Brain Science.AJOB neuroscience · 2010Article
- NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America.Harm reduction journal · 2009Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
backgroundHeroin addiction is a chronic relapsing disease, best treated with opioid-agonist substitution therapy such as methadone maintenance. However, a subset of the most severely affected individuals do not benefit sufficiently from this treatment. The North American Opiate Medication Initiative (NAOMI) is a randomized clinical trial (RCT) to evaluate the hypothesis that pharmaceutical-grade heroin, diacetylmorphine (DAM) is more effective in retaining patients and improving their outcomes than Methadone Maintenance Treatment (MMT) among those with chronic, refractory injection opioid dependence. PURPOSE/
methodsThe study aimed at randomizing 253 participants to two intervention arms: (1) MMT alone or (2) injectable opioids (DAM or hydromorphone) plus adjunctive MMT if deemed appropriate. The planned study duration was 3 years, with a 1-year intake period, 1 year of treatment, and an additional year of follow-up. The NAOMI trial was initiated in March 2005 at two Canadian sites (Vancouver and Montreal). This was the first multicenter RCT in North America to compare the relative efficacy of these different therapeutic strategies. We discuss the rationale behind the NAOMI study design, as well as the scientific and political issues and methodological challenges arising from the conduct of a trial that involves the prescription of a controlled substance to individuals with dependence on that substance. LIMITATIONS: Restrictive entry criteria led to the exclusion of many otherwise eligible participants, slowing recruitment into the study. Inability to offer DAM treatment beyond 12 months led to artificial boundary effects in the trial.
conclusionsAddiction treatment research navigates between science and politics, and evidence-based medicine is many times confronted by moral beliefs. Political considerations influence study design to a further degree than in RCTs treating less-stigmatized disorders with more-reputable medications.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.