Comparative effectiveness of buprenorphine-naloxone versus methadone for treatment of opioid use disorder: a population-based observational study protocol in British Columbia, Canada
Introduction Despite a recent meta-analysis including 31 randomised controlled trials comparing methadone and buprenorphine for the treatment of opioid use disorder, important knowledge gaps remain regarding the long-term effectiveness of different treatment modalities across individuals, including...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e036102.full |
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| author | Lawrence C McCandless Malcolm Maclure M Eugenia Socías Evan Wood Paul Gustafson Robert W Platt Bohdan Nosyk Sander Greenland Micah Piske Trevor Thomson Emanuel Krebs Natt Hongdilokkul Julie Bruneau M Ehsan Karim Judith I Tsui |
| author_facet | Lawrence C McCandless Malcolm Maclure M Eugenia Socías Evan Wood Paul Gustafson Robert W Platt Bohdan Nosyk Sander Greenland Micah Piske Trevor Thomson Emanuel Krebs Natt Hongdilokkul Julie Bruneau M Ehsan Karim Judith I Tsui |
| author_sort | Lawrence C McCandless |
| collection | DOAJ |
| description | Introduction Despite a recent meta-analysis including 31 randomised controlled trials comparing methadone and buprenorphine for the treatment of opioid use disorder, important knowledge gaps remain regarding the long-term effectiveness of different treatment modalities across individuals, including rigorously collected data on retention rates and other treatment outcomes. Evidence from real-world data represents a valuable opportunity to improve personalised treatment and patient-centred guidelines for vulnerable populations and inform strategies to reduce opioid-related mortality. Our objective is to determine the comparative effectiveness of methadone versus buprenorphine/naloxone, both overall and within key populations, in a setting where both medications are simultaneously available in office-based practices and specialised clinics.Methods and analysis We propose a retrospective cohort study of all adults living in British Columbia receiving opioid agonist treatment (OAT) with methadone or buprenorphine/naloxone between 1 January 2008 and 30 September 2018. The study will draw on seven linked population-level administrative databases. The primary outcomes include retention in OAT and all-cause mortality. We will determine the effectiveness of buprenorphine/naloxone vs methadone using intention-to-treat and per-protocol analyses—the former emulating flexible-dose trials and the latter focusing on the comparison of the two medication regimens offered at the optimal dose. Sensitivity analyses will be used to assess the robustness of results to heterogeneity in the patient population and threats to internal validity.Ethics and dissemination The protocol, cohort creation and analysis plan have been approved and classified as a quality improvement initiative exempt from ethical review (Providence Health Care Research Institute and the Simon Fraser University Office of Research Ethics). Dissemination is planned via conferences and publications, and through direct engagement and collaboration with entities that issue clinical guidelines, such as professional medical societies and public health organisations. |
| format | Article |
| id | doaj-art-b0b86c3b38c7413ca626a953dee3f503 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-b0b86c3b38c7413ca626a953dee3f5032025-01-09T07:50:13ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-036102Comparative effectiveness of buprenorphine-naloxone versus methadone for treatment of opioid use disorder: a population-based observational study protocol in British Columbia, CanadaLawrence C McCandless0Malcolm Maclure1M Eugenia Socías2Evan Wood3Paul Gustafson4Robert W Platt5Bohdan Nosyk6Sander Greenland7Micah Piske8Trevor Thomson9Emanuel Krebs10Natt Hongdilokkul11Julie Bruneau12M Ehsan Karim13Judith I Tsui14Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, CanadaDepartment of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, British Columbia, CanadaFaculty of Medicine, The University of British Columbia, Vancouver, British Columbia, CanadaFaculty of Medicine, The University of British Columbia, Vancouver, British Columbia, CanadaDepartment of Statistics, UBC, Vancouver, British Columbia, CanadaEpidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Québec, CanadaFaculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada5 Department of Epidemiology and Department of Statistics, UCLA, Los Angeles, California, USACentre for Health Evaluation and Outcome Sciences, Vancouver, British Columbia, CanadaEpidemiology and Population Health Program, BC Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, CanadaEpidemiology and Population Health Program, BC Centre for Excellence in HIV/AIDS, Vancouver, British Columbia, CanadaBritish Columbia Office of the Human Rights Commissioner, Vancouver, British Columbia, CanadaDepartment of Family Medicine and Emergency Medicine, University of Montreal, Montreal, Québec, CanadaSchool of Population and Public Health, UBC, Vancouver, British Columbia, CanadaDepartment of Medicine, Section of General Internal Medicine, University of Washington, Seattle, Washington, USAIntroduction Despite a recent meta-analysis including 31 randomised controlled trials comparing methadone and buprenorphine for the treatment of opioid use disorder, important knowledge gaps remain regarding the long-term effectiveness of different treatment modalities across individuals, including rigorously collected data on retention rates and other treatment outcomes. Evidence from real-world data represents a valuable opportunity to improve personalised treatment and patient-centred guidelines for vulnerable populations and inform strategies to reduce opioid-related mortality. Our objective is to determine the comparative effectiveness of methadone versus buprenorphine/naloxone, both overall and within key populations, in a setting where both medications are simultaneously available in office-based practices and specialised clinics.Methods and analysis We propose a retrospective cohort study of all adults living in British Columbia receiving opioid agonist treatment (OAT) with methadone or buprenorphine/naloxone between 1 January 2008 and 30 September 2018. The study will draw on seven linked population-level administrative databases. The primary outcomes include retention in OAT and all-cause mortality. We will determine the effectiveness of buprenorphine/naloxone vs methadone using intention-to-treat and per-protocol analyses—the former emulating flexible-dose trials and the latter focusing on the comparison of the two medication regimens offered at the optimal dose. Sensitivity analyses will be used to assess the robustness of results to heterogeneity in the patient population and threats to internal validity.Ethics and dissemination The protocol, cohort creation and analysis plan have been approved and classified as a quality improvement initiative exempt from ethical review (Providence Health Care Research Institute and the Simon Fraser University Office of Research Ethics). Dissemination is planned via conferences and publications, and through direct engagement and collaboration with entities that issue clinical guidelines, such as professional medical societies and public health organisations.https://bmjopen.bmj.com/content/10/9/e036102.full |
| spellingShingle | Lawrence C McCandless Malcolm Maclure M Eugenia Socías Evan Wood Paul Gustafson Robert W Platt Bohdan Nosyk Sander Greenland Micah Piske Trevor Thomson Emanuel Krebs Natt Hongdilokkul Julie Bruneau M Ehsan Karim Judith I Tsui Comparative effectiveness of buprenorphine-naloxone versus methadone for treatment of opioid use disorder: a population-based observational study protocol in British Columbia, Canada BMJ Open |
| title | Comparative effectiveness of buprenorphine-naloxone versus methadone for treatment of opioid use disorder: a population-based observational study protocol in British Columbia, Canada |
| title_full | Comparative effectiveness of buprenorphine-naloxone versus methadone for treatment of opioid use disorder: a population-based observational study protocol in British Columbia, Canada |
| title_fullStr | Comparative effectiveness of buprenorphine-naloxone versus methadone for treatment of opioid use disorder: a population-based observational study protocol in British Columbia, Canada |
| title_full_unstemmed | Comparative effectiveness of buprenorphine-naloxone versus methadone for treatment of opioid use disorder: a population-based observational study protocol in British Columbia, Canada |
| title_short | Comparative effectiveness of buprenorphine-naloxone versus methadone for treatment of opioid use disorder: a population-based observational study protocol in British Columbia, Canada |
| title_sort | comparative effectiveness of buprenorphine naloxone versus methadone for treatment of opioid use disorder a population based observational study protocol in british columbia canada |
| url | https://bmjopen.bmj.com/content/10/9/e036102.full |
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