Description of Problem: It is recommended that patients who are receiving buprenorphine for opioid use disorders (OUD) receive psychosocial treatment to improve their treatment outcomes. However, we do not know what kinds of treatment work best overall and with different kinds of patients. This project will compare two widely used psychosocial treatments individually and in combination for patients receiving buprenorphine for OUD at federally qualified health centers (FQHCs).
Methods: The project will follow 440 patients at FQHCs who have an OUD and are beginning buprenorphine treatment there. Patients will be randomized to either receive either standard medication management (MM), MM with cognitive behavioral therapy (CBT), MM with peer recovery support provided by an assigned certified recovery specialist (CRS), or MM with both CBT and a CRS. The CBT and CRS support will be provided to patients approximately weekly for three months. Participants will complete research assessments at study entry and at 3-, 6-, 9-, and 12-months post-study entry.
Outcomes: The primary outcome will be reduction in opioid use. Other outcomes will include retention in office-based opioid treatment with buprenorphine, quality of life and psychosocial functioning, abstinence from other (non-opioid) drugs, emergency department utilization, overdose rates, patient satisfaction, and provider satisfaction and job stress.
Importance to Patients: This project will provide important information about which psychosocial treatments work best and for whom, and it will help patients make more informed decisions about what types of treatment(s) will work best for them.
Patient Engagement: Our stakeholder engagement plan has three components. First, we will have a patient investigator who will play an important role in the project. Second, we will assemble a Community Advisory Board that will meet monthly and consist of patients in recovery from addiction who will provide their insight to all aspects of the project. Third, we will have a Study Advisory Committee with dedicated representatives from various national and local stakeholder groups that will meet regularly. They will play an important role in ensuring that the project addresses the needs of patients, people are made aware of study findings, and that other programs can use the findings to help their patients.
*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.