A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse

Summary

This trial evaluates two standard of care treatments for opioid addiction: methadone and buprenorphine/naloxone. In order to improve patient care, the study will address real-world treatment conditions, including strict regulations for methadone dosing (i.e. initially dispensed daily at the pharmacy until stabilisation) vs. flexible take-home dosing for buprenorphine/naloxone. The OPTIMA study is designed with the intention to support patient-provider decision-making and evaluate health related outcomes with the overall aim of improving treatment outcomes through enhancing patient-centered approaches in clinical care.

Timeline

Start

2017-10-02

Primary completion

2020-03-31

Completion

2020-12-31

Outcome

Met primary endpoint

paper The buprenorphine/naloxone flexible model of care was safe and noninferior to methadone in reducing opioid use PMID 35702828 ↗

Publications

• Bastien G, Abboud A, McAnulty C, Mahroug A, Le Foll B, Socias ME, Juteau LC, Dubreucq S, Jutras-Aswad D. Concordance Between Urine Drug Screening and Self-Reported Use in the Context of a Pragmatic Randomized-Controlled Trial in People with Prescription-Type Opioid Use Disorder: Concordance entre le depistage de drogues dans l'urine et l'usage autodeclare dans le contexte d'un essai pragmatique controle a repartition aleatoire chez des personnes presentant un trouble lie a l'usage d'opioides vendus sur ordonnance. Can J Psychiatry. 2026 Jan;71(1):41-52. doi: 10.1177/07067437251367180. Epub 2025 Aug 28.
• Bouthillier A, Bastien G, McAnulty C, Bakouni H, Le Foll B, Socias ME, Jutras-Aswad D. Opioid consumption frequency and its associations with potential life problems during opioid agonist treatment in individuals with prescription-type opioid use disorder: exploratory results from the OPTIMA Study. Harm Reduct J. 2025 Feb 8;22(1):14. doi: 10.1186/s12954-025-01157-4.
• Langlois J, Fairbairn N, Jutras-Aswad D, Le Foll B, Lim R, Socias ME. Characterising methamphetamine/amphetamine use among opioid agonist therapy-seeking adults with prescription-type opioid use disorder in Canada. Drug Alcohol Rev. 2024 Nov;43(7):1905-1912. doi: 10.1111/dar.13863. Epub 2024 May 9.
• Bastien G, Abboud A, McAnulty C, Elkrief L, Ledjiar O, Socias ME, Le Foll B, Bahji A, Brissette S, Marsan S, Jutras-Aswad D. Impact of Depressive Symptom Severity on Buprenorphine/Naloxone and Methadone Outcomes in People With Prescription-Type Opioid Use Disorder: Results From a Pragmatic Randomized Controlled Trial. J Dual Diagn. 2024 Jul-Sep;20(3):189-200. doi: 10.1080/15504263.2024.2329267. Epub 2024 Apr 5.
• Socias ME, Cui Z, Le Foll B, Lei J, Stewart S, Anand R, Jutras-Aswad D. Sexually transmitted and blood-borne infection risk reduction with methadone and buprenorphine/naloxone among people with prescription-type opioid use disorder: Findings from a Canadian pragmatic randomized trial. HIV Med. 2024 Jul;25(7):817-825. doi: 10.1111/hiv.13636. Epub 2024 Mar 20.
• Bahji A, Bastien G, Bach P, Choi J, Le Foll B, Lim R, Jutras-Aswad D, Socias ME. The Association Between Self-Reported Anxiety and Retention in Opioid Agonist Therapy: Findings From a Canadian Pragmatic Trial. Can J Psychiatry. 2024 Mar;69(3):172-182. doi: 10.1177/07067437231194385. Epub 2023 Sep 12.
• Elkrief L, Bastien G, McAnulty C, Bakouni H, Hebert FO, Socias ME, Le Foll B, Lim R, Ledjiar O, Marsan S, Brissette S, Jutras-Aswad D; OPTIMA Research Group within the Canadian Research Initiative in Substance Misuse. Differential effect of cannabis use on opioid agonist treatment outcomes: Exploratory analyses from the OPTIMA study. J Subst Use Addict Treat. 2023 Jun;149:209031. doi: 10.1016/j.josat.2023.209031. Epub 2023 Mar 30.
• Bastien G, McAnulty C, Ledjiar O, Socias ME, Le Foll B, Lim R, Hassan AN, Brissette S, Marsan S, Talbot A, Jutras-Aswad D; OPTIMA Research Group within the Canadian Research Initiative in Substance Misuse. Effects of Buprenorphine/Naloxone and Methadone on Depressive Symptoms in People with Prescription Opioid Use Disorder: A Pragmatic Randomised Controlled Trial. Can J Psychiatry. 2023 Aug;68(8):572-585. doi: 10.1177/07067437221145013. Epub 2022 Dec 14.
• McAnulty C, Bastien G, Eugenia Socias M, Bruneau J, Le Foll B, Lim R, Brissette S, Ledjiar O, Marsan S, Talbot A, Jutras-Aswad D; OPTIMA Research Group within the Canadian Research Initiative in Substance Misuse. Buprenorphine/naloxone and methadone effectiveness for reducing craving in individuals with prescription opioid use disorder: Exploratory results from an open-label, pragmatic randomized controlled trial. Drug Alcohol Depend. 2022 Oct 1;239:109604. doi: 10.1016/j.drugalcdep.2022.109604. Epub 2022 Aug 17.
• 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 Misuse. 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. Am J Psychiatry. 2022 Oct;179(10):726-739. doi: 10.1176/appi.ajp.21090964. Epub 2022 Jun 15.
• Socias ME, Ahamad K, Le Foll B, Lim R, Bruneau J, Fischer B, Wild TC, Wood E, Jutras-Aswad D. The OPTIMA study, buprenorphine/naloxone and methadone models of care for the treatment of prescription opioid use disorder: Study design and rationale. Contemp Clin Trials. 2018 Jun;69:21-27. doi: 10.1016/j.cct.2018.04.001. Epub 2018 Apr 5.

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