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  • Title: Flexible Buprenorphine/Naloxone Model of Care for Reducing Opioid Use in Individuals With Prescription-Type Opioid Use Disorder: An Open-Label, Pragmatic, Noninferiority Randomized Controlled Trial.
    Author: Jutras-Aswad D, Le Foll B, Ahamad K, Lim R, Bruneau J, Fischer B, Rehm J, Wild TC, Wood E, Brissette S, Gagnon L, Fikowski J, Ledjiar O, Masse B, Socias ME, OPTIMA Research Group within the Canadian Research Initiative in Substance MisuseResearch Centre, Centre Hospitalier de l'Université de Montréal, Montreal (Jutras-Aswad, Bruneau, Gagnon, Brissette); Department of Psychiatry and Addictology, Faculty of Medicine, Université de Montréal, Montreal (Jutras-Aswad); Department of Pharmacology and Toxicology and Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto (Le Foll); Department of Psychiatry, University of Toronto, Toronto (Le Foll, Fischer, Rehm); Dalla Lana School of Public Health, University of Toronto, Toronto (Le Foll, Rehm); Translational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Center for Addiction and Mental Health (CAMH), Toronto (Le Foll); Acute Care Program, CAMH, Toronto (Le Foll); British Columbia Centre on Substance Use, Vancouver (Ahamad, Wood, Fikowski, Socias); Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver (Ahamad); Department of Family Medicine and Psychiatry, Cumming School of Medicine, University of Calgary, Alberta, Canada (Lim); Department of Family and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal (Bruneau, Brissette); Schools of Population Health and Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand (Fischer); Centre for Applied Research in Mental Health and Addiction, Faculty of Health Science, Simon Fraser University, Vancouver (Fischer); Department of Psychiatry, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil (Fischer); Institute for Mental Health Policy Research, CAMH, Toronto (Rehm); Institute of Clinical Psychology and Psychotherapy Centre and Centre for Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany (Rehm); Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow (Rehm); School of Public Health, University of Alberta, Edmonton, Canada (Wild); Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver (Wood, Socias); Unité de Recherche Clinique Appliquée, Research Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal (Ledjiar, Masse); Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montreal (Masse)..
    Journal: Am J Psychiatry; 2022 Oct; 179(10):726-739. PubMed ID: 35702828.
    Abstract:
    OBJECTIVE: Extensive exposure to prescription-type opioids has resulted in major harm worldwide, calling for better-adapted approaches to opioid agonist therapy. The authors aimed to determine whether flexible take-home buprenorphine/naloxone is as effective as supervised methadone in reducing opioid use in prescription-type opioid consumers with opioid use disorder. METHODS: This seven-site, pan-Canadian, 24-week, pragmatic, open-label, noninferiority, two-arm parallel randomized controlled trial involved treatment-seeking adults with prescription-type opioid use disorder. Participants were randomized in a 1:1 ratio to treatment with sublingual buprenorphine/naloxone (target dosage, 8 mg/2 mg to 24 mg/6 mg per day; flexible take-home dosing) or oral methadone (≈60-120 mg/day; closely supervised). The primary outcome was the proportion of opioid-free urine drug screens over 24 weeks (noninferiority margin, 15%). All randomized participants were analyzed, excluding one who died shortly after randomization, for the primary analysis (modified intention-to-treat analysis). RESULTS: Of 272 participants recruited (mean age, 39 years [SD=11]; 34.2% female), 138 were randomized to buprenorphine/naloxone and 134 to methadone. The mean proportion of opioid-free urine drug screens was 24.0% (SD=34.4) in the buprenorphine/naloxone group and 18.5% (SD=30.5) in the methadone group, with a 5.6% adjusted mean difference (95% CI=-0.3, +∞). Participants in the buprenorphine/naloxone group had 0.47 times the odds (95% CI=0.24, 0.90) of being retained in the assigned treatment compared with those in the methadone group. Overall, 24 drug-related adverse events were reported (12 in the buprenorphine/naloxone group [N=8/138; 5.7%] and 12 in the methadone group [N=12/134; 9.0%]) and mostly included withdrawal, hypogonadism, and overdose. CONCLUSIONS: The buprenorphine/naloxone flexible model of care was safe and noninferior to methadone in reducing opioid use among people with prescription-type opioid use disorder. This flexibility could help expand access to opioid agonist therapy and reduce harms in the context of the opioid overdose crisis.
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