M Eugenia Socias1, Keith Ahamad2, Bernard Le Foll3, Ron Lim4, Julie Bruneau5, Benedikt Fischer6, T Cameron Wild7, Evan Wood8, Didier Jutras-Aswad9. 1. British Columbia Centre on Substance Use, St. Paul's Hospital, 608-1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada; Department of Medicine, Faculty of Medicine, University of British Columbia, 608-1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada. Electronic address: esocias@cfenet.ubc.ca. 2. British Columbia Centre on Substance Use, St. Paul's Hospital, 608-1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada; Department of Family Practice, Faculty of Medicine, University of British Columbia, 3rd Floor David Strangway Building, 5950 University Boulevard, Vancouver, BC V6T 1Z3, Canada. 3. Centre for Addiction and Mental Health, 33 Russell Street, Toronto, ON M5S 2S1, Canada; Department of Family and Community Practice, University of Toronto, 500 University Avenue, 5th floor, Toronto, ON M5G 1V7, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, ON M5T 1R8, Canada. 4. Department of Medicine, Cumming School of Medicine, University of Calgary, 2500 University Drive NW, Calgary, AB T2N 1N4, Canada. 5. Research Center, Centre hospitalier de l'Université de Montréal (CRCHUM), 900 Saint Denis Street, Montréal, QC H2X 0A9, Canada; Department of Family Medicine, Faculty of Medicine, Université de Montréal, C.P. 6128, Succursale Centre-ville, Montréal, QC H3C 3J7, Canada. 6. Centre for Addiction and Mental Health, 33 Russell Street, Toronto, ON M5S 2S1, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, ON M5T 1R8, Canada; Centre for Applied Research in Mental Health and Addiction, Faculty of Health Sciences, Simon Fraser University, Suite 2400, 515 W. Hastings Street, Vancouver, BC V6B 5K3, Canada. 7. School of Public Health, University of Alberta, 3-300 Edmonton Clinic Health Academy 11405-87 Av, Edmonton, AL T6G 1C9, Canada. 8. British Columbia Centre on Substance Use, St. Paul's Hospital, 608-1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada; Department of Medicine, Faculty of Medicine, University of British Columbia, 608-1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada. 9. Department of Medicine, Cumming School of Medicine, University of Calgary, 2500 University Drive NW, Calgary, AB T2N 1N4, Canada; Department of Psychiatry, Faculty of Medicine, Université de Montréal, C.P. 6128, Succursale Centre-ville, Montréal, QC H3C 3J7, Canada.
Abstract
BACKGROUND: Rates of non-medical use of opioids, and opioid use disorders (OUD) have been rising throughout North America. Methadone and buprenorphine/naloxone are the recommended first-line treatment options for OUD in Canada. Most studies to date have been conducted among heroin users, in controlled settings, and using similar strict dosing schedules (i.e., daily witnessed ingestion) despite buprenorphine/naloxone's superior safety profile, which allows a more flexible take-home dosing schedule. This study was designed to assess the relative effectiveness of buprenorphine/naloxone- and methadone-based models of opioid agonist therapy (OAT) for the treatment of prescription opioid use disorder (POUD) in routine clinical care. METHODS: OPTIMA is a multicenter, open-label, pragmatic, randomized, two-arm, non-inferiority, 24-week study comparing the relative effectiveness of buprenorphine/naloxone (provided via flexible take-home doses) to methadone (provided via daily witnessed ingestion) models of OAT for the treatment of POUD. Approximately 276 non-pregnant adults meeting DSM-5 criteria for OUD, currently not in OAT, will be randomized across 7 Canadian sites. The primary outcome is reduction of non-medical opioid use, measured by bi-weekly urine drug screens during the 24-week study period. Secondary outcomes include treatment retention and satisfaction, safety, medication adherence, and patient engagement. DISCUSSION: The OPTIMA study is the first randomized clinical trial to compare the relative effectiveness of buprenorphine/naloxone (flexible take-home doses) versus methadone (daily witnessed ingestion) models of OAT for POUD in real-world clinical settings. This study will generate urgently needed evidence towards treatment options to guide the health system response to the ongoing opioid crisis. CLINICAL TRIAL REGISTRATION: NCT03033732.
RCT Entities:
BACKGROUND: Rates of non-medical use of opioids, and opioid use disorders (OUD) have been rising throughout North America. Methadone and buprenorphine/naloxone are the recommended first-line treatment options for OUD in Canada. Most studies to date have been conducted among heroin users, in controlled settings, and using similar strict dosing schedules (i.e., daily witnessed ingestion) despite buprenorphine/naloxone's superior safety profile, which allows a more flexible take-home dosing schedule. This study was designed to assess the relative effectiveness of buprenorphine/naloxone- and methadone-based models of opioid agonist therapy (OAT) for the treatment of prescription opioid use disorder (POUD) in routine clinical care. METHODS: OPTIMA is a multicenter, open-label, pragmatic, randomized, two-arm, non-inferiority, 24-week study comparing the relative effectiveness of buprenorphine/naloxone (provided via flexible take-home doses) to methadone (provided via daily witnessed ingestion) models of OAT for the treatment of POUD. Approximately 276 non-pregnant adults meeting DSM-5 criteria for OUD, currently not in OAT, will be randomized across 7 Canadian sites. The primary outcome is reduction of non-medical opioid use, measured by bi-weekly urine drug screens during the 24-week study period. Secondary outcomes include treatment retention and satisfaction, safety, medication adherence, and patient engagement. DISCUSSION: The OPTIMA study is the first randomized clinical trial to compare the relative effectiveness of buprenorphine/naloxone (flexible take-home doses) versus methadone (daily witnessed ingestion) models of OAT for POUD in real-world clinical settings. This study will generate urgently needed evidence towards treatment options to guide the health system response to the ongoing opioid crisis. CLINICAL TRIAL REGISTRATION: NCT03033732.
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