The Swiss heroin trials: testing alternative approaches. Editorial

Drug & Alcohol Services South Australia, Tarndarnya, South Australia, Australia
BMJ Clinical Research (Impact Factor: 14.09). 02/1998; 316(7132):639. DOI: 10.1136/bmj.316.7132.639
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Available from: Michael Farrell, Mar 13, 2014
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    • "In fact, HAT is not meant to replace MMT, but to be another available treatment option. One that would have a small but very important role in the addiction treatment system [46]. Even in two of the three countries where HAT exists as a regular program, participants in the program account for less than 10% of those in substitution treatment in those countries [31,45]. "
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    ABSTRACT: Opioid addiction is a chronic, relapsing disease and remains a major public health challenge. Despite important expansions of access to conventional treatments, there are still significant proportions of affected individuals who remain outside the reach of the current treatment system and who contribute disproportionately to health care and criminal justice costs as well as to public disorder associated with drug addiction.The NAOMI study is a Phase III randomized clinical trial comparing injectable heroin maintenance to oral methadone. The study has ethics board approval at its Montréal and Vancouver sites, as well as from the University of Toronto, the New York Academy of Medicine and Johns Hopkins University.The main objective of the NAOMI Study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade opioid agonist is more effective than methadone alone in recruiting, retaining, and benefiting chronic, opioid-dependent, injection drug users who are resistant to current standard treatment options. The case study submitted chronicles the challenges of getting a heroin assisted treatment trial up and running in North America. It describes: a brief background on opioid addiction; current standard therapies for opioid addiction; why there is/was a need for a heroin assisted treatment trial; a description of heroin assisted treatment; the beginnings of creating the NAOMI study in North America; what is the NAOMI study; the science and politics of the NAOMI study; getting NAOMI started in Canada; various requirements and restrictions in getting the study up and running; recruitment into the study; working with the media; a status report on the study; and a brief conclusion from the authors' perspectives. As this is a case study, there are no specific results or main findings listed. The case study focuses on: the background of the study; what it took to get the study started in Canada; the unique requirements and conditions of getting a site, and the study, approved; working with the media; recruitment into the study; a brief status report on the study; and a brief conclusion from the authors' perspectives. registration number: NCT00175357.
    Full-text · Article · Feb 2009 · Harm Reduction Journal
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    • "I n 1994, the Swiss program for medical prescription of narcotics (PROVE) started to treat opioid dependent patients with injectable opioid treatment (IOT) using either intravenous (IV) heroin-assisted treatment (HAT) or IV methadone maintenance treatment (MMT). Following initial controversy (Bammer et al 1999; Farrell and Hall 1998; Perneger et al 1998; Rusche 1999; Satel and Aeschbach 1999; Uchtenhagen et al 1997; World Health Organization 1999), IOT now (Drucker 2001; Rehm et al 2001) seems to fulfil the expectations in terms of retaining dependent patients in treatment and lowering criminal activities as well as high-risk sexual behavior and is presently available in the Netherlands (Copeman 2002; Sheldon 2002; van Kolfschooten 2002), Germany, and the United Kingdom. There is growing debate about initiating heroin trials in other countries, however (e.g., Italy, Spain, and the United States; Kuo et al 2000). "
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    ABSTRACT: There is a growing debate about injectable opioid treatment programs in many Western countries. This is the first placebo-controlled study of the safety of injectable opioids in a controlled treatment setting. Twenty-five opioid-dependent patients on intravenous (IV) heroin or IV methadone maintenance treatment were randomly assigned to either their individual prescribed IV maintenance dose or placebo. Acute drug effects were recorded, focusing on electrocardiography, respiratory movements, arterial blood oxygen saturation, and electroencephalography (EEG). After heroin injection, marked respiratory depression progressing to a Cheyne-Stokes pattern occurred. Peripheral arterial blood oxygenation decreased to 78.9 +/- 8.7% (mean +/- SD) ranging from 52%-90%. During hypoxia, 7 of the 16 subjects experienced intermittent and somewhat severe bradycardia. Five subjects exhibited paroxysmal EEG patterns. After methadone injection, respiratory depression was less pronounced than after heroin injection. No relevant bradycardia was noted. Opioid doses commonly prescribed in IV opioid treatment induce marked respiratory and circulatory depression, as well as occasionally irregular paroxysmal EEG activity. Further studies are needed to optimize the clinical practice of IV opioid treatment to prevent serious complications. Moreover, the extent of the observed effects raises questions about the appropriateness of IV opioid treatment in the present form.
    Full-text · Article · Nov 2003 · Biological Psychiatry
    • "These facilities are clearly distinguishable from illegal shooting galleries, which operate for profit and have little regard for the health and safety of patrons [4 – 6]. DCRs are also distinct from heroin prescription programmes, where severely opioid dependent clients are dispensed heroin under supervision as part of a high threshold drug treatment programme [7]. DCRs have been characterized as a ''middle ground between public heath and public order concerns'' as they occupy an important niche in the management of open drug scenes and the provision of harm reduction services [3] [8] [9]. "
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    ABSTRACT: The topic of drug consumption facilities or rooms (DCRs) was reviewed by Dolan, Kimber and others in Harm Reduction Digest 10, published in the September 2000 issue of DAR. As one of the first English language papers on the topic this paper has been cited extensively. Now, 3 years on, these authors and have brought together an international team of experts to revisit the topic. In this update they: (i) highlight where DCRs are operating or under consideration, (ii) review briefly new literature and (iii) discuss future directions. This Digest is a 'must read' for policy makers, advocates and practitioners in the drug field.
    No preview · Article · Jul 2003 · Drug and Alcohol Review
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