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Identifying optimal psychosocial interventions for patients receiving office-based buprenorphine
Investigator (PI): Festinger, David
Performing Organization (PO): (Current): Philadelphia College of Osteopathic Medicine, School of Professional and Applied Psychology, Department of Clinical Psychology / (215) 871-6439
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2019
Final Year: 2024
Record Source/Award ID: PCORI/ OBOT-2018C2-13158
Funding: Total Award Amount: $5,536,997
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Description of problem: It is recommended that patients who are receiving buprenorphine for opioid use disorder (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: Participants (n=440) will be patients at FQHCs who have an OUD and are beginning buprenorphine treatment there. Patients will be randomized to 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 abstinence from opioid use. Other outcomes will include (1) retention in office-based opioid treatment with buprenorphine, (2) quality of life and psychosocial functioning, (3) abstinence from other (non-opioid) drugs, (4) emergency department utilization, (5) overdose rates, (6) patient satisfaction, and (7) provider satisfaction and job stress. Importance to patients: This project is important because it 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.
MeSH Terms:
  • Buprenorphine /*therapeutic use
  • Community Mental Health Centers /*organization & administration
  • Drug Overdose /prevention & control
  • Emergency Service, Hospital
  • Humans
  • Job Satisfaction
  • Medication Adherence
  • Medication Assisted Treatment of Opioid
  • Outpatients
  • Patient Satisfaction
  • Peer Group
  • Program Development
  • Psychological Stress
  • Quality of Life
  • Randomized Controlled Trials as Topic
Country: United States
State: Pennsylvania
Zip Code: 19131
UI: 20202354
CTgovId: NCT04257214
Project Status: Ongoing