Behavioral Optimization for Overcoming Suboptimal Treatment Retention (BUP-BOOSTeR)
- Sponsor
- Boston University
- Study ID
- NCT07607743
- Status
- Not Yet Recruiting
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Conditions
- Opioid Use Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Behavioral Activation (BA) — BEHAVIORALTrained study interventionists will deliver the manualized BA intervention aimed at increasing meaningful and enjoyable non-substance-related activities in early recovery. This intervention will include 12 individual sessions delivered to participants every other week for 6 months. The BA intervention will be delivered remotely by telephone or video visit to minimize treatment burden on patients.
- Attendance Reinforcement (AR) — BEHAVIORALA voucher incentive protocol will be implemented with increasing rewards based on clinical attendance at outpatient addiction treatment visits. The timing of clinical visits will be determined by site-specific usual care practices at both sites. Participants are expected to earn a range of payments for visit attendance according to their unique clinical schedule (which is dictated by their addiction medicine clinical team, not by research investigators).
- Peer-Delivered Motivational Interviewing (PDMI) — BEHAVIORALTrained study peer recovery coaches will deliver a multi-session intervention aimed at increasing treatment confidence for treatment continuation and providing social support during early recovery. The peer recovery coach will deliver brief MI (20-minute) individual sessions remotely every other week over the 6-month period (total 12 sessions). Peer interventionists will also be informed about local recovery resources to provide navigation support individually. PDMI will be delivered remotely by telephone or video visit.
Study Details
Buprenorphine, a medication for opioid use disorder (MOUD), is associated with decreased opioid overdose and all-cause mortality. Treatment outcomes improve if patients remain on MOUD for at least six months, a period recommended by expert guidelines, although most studies report retention on MOUD of 50-65% at 3-6 months. Psychosocial interventions have the potential to improve MOUD treatment retention particularly when applied in combination in efficient delivery systems. The objective of this study is to develop an effective and efficient multicomponent intervention to increase buprenorphine retention at 6 months through an optimization trial.
Key Dates
- First listed
- May 26, 2026
- Start date
- Sep 30, 2026
- Status verified
- May 2026
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Behavioral ActivationParticipants in this arm will receive the behavioral activation intervention.
- Experimental: Attendance ReinforcementParticipants in this arm will receive the Attendance Reinforcement intervention.
- Experimental: Peer-Delivered Motivational InterviewingParticipants in this arm will receive the Peer-Delivered Motivational Interviewing Intervention.
- Experimental: Behavioral Activation + Attendance ReinforcementParticipants in this arm will receive the Behavioral Activation and Attendance Reinforcement interventions.
- Experimental: Behavioral Activation + Peer-Delivered Motivational InterviewingParticipants in this arm will receive the Behavioral Activation and Peer-Delivered Motivational Interviewing interventions.
- Experimental: Attendance Reinforcement + Peer-Delivered Motivational InterviewingParticipants in this arm will receive the Attendance Reinforcement and Peer-Delivered Motivational Interviewing interventions.
- Experimental: Behavioral Activation + Attendance Reinforcement + Peer-Delivered Motivational InterviewingParticipants in this arm will receive the Behavioral Activation, Attendance Reinforcement, and Peer-Delivered Motivational Interviewing interventions.
- No Intervention: Treatment As UsualParticipants randomized to this arm will receive usual care at their office based addiction treatment facility.
Primary Outcome Measure
Number of participants with buprenorphine retention [ Time Frame: 6 months ]
Central Contacts
- Michael Stein, MD(617) 638-5042
- Sally Bendiks, MPH(617) 414-3802
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