Optimizing patient centered-care: A pragmatic randomized control trial comparing models of care in the management of prescription opioid misuse (OPTIMA)

Although methadone has long been the standard of care for the treatment of opioid use disorder in Canada, there is growing consensus that the superior safety profile of buprenorphine/naloxone, as well as other comparative advantages, supports its use as a first-line therapy for opioid use disorder. The OPTIMA trial aims to evaluate these two treatment options within a Canadian practice‐based framework, generating evidence that is directly relevant to a recognized national priority in public health.

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 opioid agonist treatments for people who use drugs in real-world clinical settings. The effectiveness of the two treatments in reducing opioid use is compared in the 6-month, open-label, multi-site pragmatic randomized trial involving over 250 participants recruited from all four CRISM Nodes.

The evidence generated from this study will be used to inform patient care and improve overall health outcomes.

The OPTIMA Protocol has been published. Access it here: