Opioid use has increased to epidemic levels in the United States and has been associated with a dramatic increase in overdose deaths. Buprenorphine is a safe, well-tolerated, and evidence-based medication for opioid use disorder that can be prescribed in office-based treatment settings. Office-based buprenorphine could be an effective, patient-centered way to expand treatment for opioid use disorder, and thereby combat the opioid epidemic.
However, office-based buprenorphine has three limitations that must be addressed to facilitate the safe and effective expansion of buprenorphine treatment: Many patients discontinue buprenorphine treatment prematurely, some patients divert buprenorphine for illicit use, and many patients continue to use illicit opioids during buprenorphine treatment.
Methods: This project will address these limitations by using a psychosocial approach known as Contingency Management. Contingency Management interventions provide incentives (e.g., vouchers or reloadable credit cards) to substance abuse patients when they meet therapeutic goals. This project will compare the effectiveness of two Contingency Management interventions—which we have named Buprenorphine Adherence and Opiate Abstinence and Buprenorphine Adherence Only—and Standard Medical Management for treating adults with opioid use disorder.
For this study, 375 participants will be randomly assigned to one of the three groups. Buprenorphine Adherence and Opiate Abstinence and Buprenorphine Adherence Only participants will receive incentives for daily buprenorphine use. Buprenorphine Adherence and Opiate Abstinence participants also will receive incentives for providing opiate-negative saliva samples. Daily buprenorphine use and opiate abstinence will both be remotely verified using smartphone-enabled, commercially available video directly observed therapy (Video DOT) provided by emocha Mobile Health, Inc. Standard Medical Management participants will receive office-based buprenorphine treatment, including office visits to address patient concerns, recent drug use, and buprenorphine effects and side effects. All participants will complete assessments every 4 weeks during a 12-week intervention period and every 13 weeks during a 1-year follow-up.
Outcomes: The primary outcomes will be buprenorphine adherence and opiate abstinence as assessed by urinalysis results every 4 weeks during the intervention. Secondary outcomes will include measures of importance to patients and providers: buprenorphine diversion, treatment retention, psychosocial functioning and quality of life, patient treatment satisfaction, overdose and risk of overdose, and post-intervention effects.
Importance to Patients: The majority of individuals who suffer from an opioid use disorder do not receive evidence-based medication-assisted treatment, and only a fraction of individuals who do receive treatment achieve long-term remission. Office-based buprenorphine could be an ideal pharmacotherapy in efforts to improve access to evidence-based treatment for opioid use disorder, and the addition of Contingency Management could greatly enhance treatment outcomes. If the proposed intervention is effective, it could encourage more medical professionals to prescribe buprenorphine, and could improve patients’ ability to access and succeed in office-based buprenorphine treatment.
Patient and Stakeholder Engagement: This project will involve partnerships with key stakeholder groups that will contribute expertise that is critical to the success of the project. Patients, providers, payers, industry, community organizations, and advocacy groups will be actively engaged in the planning, implementation, and dissemination of this project.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.