Behavioral Optimization for Overcoming Suboptimal Treatment Retention (BUP-BOOSTeR)

NCT07607743 | Not Yet Recruiting DMC

• 2 other identifiers: H-46388R01DA062408
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

Behavioral activation; Attendance reinforcement; Peer motivational interviewing; Multiphase Optimization STrategy (MOST); Buprenorphine

Outcome Measures

Primary Outcomes (1)

• Number of participants with buprenorphine retention

  Buprenorphine retention will be defined as any of the following: 1) EHR confirmation of a prescription whose end date extends beyond the day of the 6-month assessment OR long-acting injectable buprenorphine (LAIB) administration within the last 4 weeks (for monthly Sublocade or Brixadi) or within the last 7 days (for weekly Brixadi); 2) Self-report of an active buprenorphine prescription or active LAIB administration (as previously defined); 3) Verification of medication including visualization of a pill bottle, film packet, or verification of a record of an LAIB administration event (by photo or video confirmation) for persons who change their care to another clinic during the study period

  6 months

Study Arms (8)

Behavioral Activation

EXPERIMENTAL

Participants in this arm will receive the behavioral activation intervention.

Behavioral: Behavioral Activation (BA)

Attendance Reinforcement

EXPERIMENTAL

Participants in this arm will receive the Attendance Reinforcement intervention.

Behavioral: Attendance Reinforcement (AR)

Peer-Delivered Motivational Interviewing

EXPERIMENTAL

Participants in this arm will receive the Peer-Delivered Motivational Interviewing Intervention.

Behavioral: Peer-Delivered Motivational Interviewing (PDMI)

Behavioral Activation + Attendance Reinforcement

EXPERIMENTAL

Participants in this arm will receive the Behavioral Activation and Attendance Reinforcement interventions.

Behavioral: Behavioral Activation (BA); Behavioral: Attendance Reinforcement (AR)

Behavioral Activation + Peer-Delivered Motivational Interviewing

EXPERIMENTAL

Participants in this arm will receive the Behavioral Activation and Peer-Delivered Motivational Interviewing interventions.

Behavioral: Behavioral Activation (BA); Behavioral: Peer-Delivered Motivational Interviewing (PDMI)

Attendance Reinforcement + Peer-Delivered Motivational Interviewing

EXPERIMENTAL

Participants in this arm will receive the Attendance Reinforcement and Peer-Delivered Motivational Interviewing interventions.

Behavioral: Attendance Reinforcement (AR); Behavioral: Peer-Delivered Motivational Interviewing (PDMI)

Behavioral Activation + Attendance Reinforcement + Peer-Delivered Motivational Interviewing

EXPERIMENTAL

Participants in this arm will receive the Behavioral Activation, Attendance Reinforcement, and Peer-Delivered Motivational Interviewing interventions.

Behavioral: Behavioral Activation (BA); Behavioral: Attendance Reinforcement (AR); Behavioral: Peer-Delivered Motivational Interviewing (PDMI)

Treatment As Usual

NO INTERVENTION

Participants randomized to this arm will receive usual care at their office based addiction treatment facility.

Interventions

Behavioral Activation (BA) BEHAVIORAL

Trained 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.

Behavioral Activation; Behavioral Activation + Attendance Reinforcement; Behavioral Activation + Attendance Reinforcement + Peer-Delivered Motivational Interviewing; Behavioral Activation + Peer-Delivered Motivational Interviewing

Attendance Reinforcement (AR) BEHAVIORAL

A 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).

Attendance Reinforcement; Attendance Reinforcement + Peer-Delivered Motivational Interviewing; Behavioral Activation + Attendance Reinforcement; Behavioral Activation + Attendance Reinforcement + Peer-Delivered Motivational Interviewing

Peer-Delivered Motivational Interviewing (PDMI) BEHAVIORAL

Trained 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.

Attendance Reinforcement + Peer-Delivered Motivational Interviewing; Behavioral Activation + Attendance Reinforcement + Peer-Delivered Motivational Interviewing; Behavioral Activation + Peer-Delivered Motivational Interviewing; Peer-Delivered Motivational Interviewing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Meet DSM V criteria for opioid use disorder during the past year
• Be a patient in Office Based Addiction Treatment who has initiated buprenorphine in the last 30 days AND has had no use of prescribed buprenorphine in the 7 days before the current treatment episode AND has not received long-acting injectable buprenorphine in the 6 weeks before the current treatment episodes OR Be a person within the first 30 days of release from a carceral setting who is taking any formulation of buprenorphine for their OUD and who is within their first 30 days of intake at OBAT.
• Be willing to provide informed consent, be randomized, and complete study materials
• Be able to speak and read English sufficiently to complete study intervention and procedures
• Be willing to provide the study access to their electronic medical records
• Have no plans to change Office Based Addiction Treatment clinics during the study

You may not qualify if:

• Be receiving hospice or other end of life medical care

Sponsors & Collaborators

• Boston University: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael Stein, MD

  BUSPH, Health Law, Policy & Management

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Stein, MD

CONTACT

(617) 638-5042; mdstein@bu.edu

Sally Bendiks, MPH

CONTACT

(617) 414-3802; Sally.Bendiks@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share