OPTIMA

National CRISM Project

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

The trial has closed recruitment in Calgary. Thank you to everyone who contributed to successful completion of this study.

A Prevention and treatment of opioid use disorder (OUD) in Canada has become an urgent public health priority. There are a number of evidence-based options available for the treatment of OUD, but only two opioid agonist medications are currently approved in Canada for opioid agonist therapy (OAT): methadone and buprenorphine. Methadone has emerged as standard of care, while in other jurisdictions, including the United States, buprenorphine/naloxone is the pharmacotherapy of choice for treatment of OUD. Unfortunately, adherence to long-term maintenance treatment, either with methadone or buprenorphine/naloxone, is associated with several challenges that undermine the population impact of these treatments. For instance, because of its low therapeutic index, strict programmatic regulations (e.g., daily witnessed consumption) govern initiation of methadone administration in most jurisdictions, and these requirements have a negative impact on motivation among opioid-dependent individuals to participate in methadone maintenance treatment. In contrast, while the improved safety profile of buprenorphine/naloxone with respect to overdose can permit flexible take-home dosing, studies have also demonstrated significant barriers to uptake, also stemming from patient unwillingness to engage with long-term maintenance therapy. Often, this unwillingness reflects patient preferences to progressively taper off opioids rather than participate in long-term maintenance treatment with opioid agonists.

A number of problems will be addressed in the proposed study; all are aimed at providing evidence to optimize care for individuals who have become addicted to opioids and are actively using prescription opioids. First, research to date on the relative efficacy of buprenorphine/naloxone versus methadone has limited external validity regarding the care of prescription opioid (PO) users. To our knowledge, no previous randomized trials have examined the relative benefits of buprenorphine/naloxone and methadone when offered within a realistic model of care, adapted to the respective safety profiles of these medications and in line with current clinical practice guidelines. Thus, questions remain as to how these medications perform among PO-dependent individuals in realistic treatment scenarios.

Second, uptake of OAT continues to be problematic in the target population. Among the key barriers is that patients often express a preference for short term opioid tapering over long-term maintenance therapy, and can experience barriers to accessing addiction care when programs exclusively offer maintenance therapy. Novel strategies are required to engage and retain individuals in treatment, particularly among those who are reluctant to participate in long-term agonist therapy programs. Clinical trials to date have not accommodated participant preferences, flexibility or transitions between tapered or maintenance agonist therapy. In this context, it is important to determine whether programs that are explicitly designed to support ongoing shared patient-provider decision making processes can potentially increase engagement in long-term agonist treatment or rates of successful taper, and subsequently, improve overall health outcomes.  These issues will be explored in a 6-month, open-label, multi-site pragmatic randomized trial involving over 200 clients recruited from all 4 CRISM Nodes.