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

BUP-BOOSTeR: Behavioral Optimization for Overcoming Suboptimal Treatment Retention

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: Behavioral Activation (BA); Behavioral: Peer-Delivered Motivational Interviewing (PDMI); Behavioral: Attendance Reinforcement (AR)

Detailed Description

The investigators will leverage the Multiphase Optimization STrategy (MOST) framework for developing, optimizing, and evaluating a multicomponent behavioral intervention. The impact of three psychosocial intervention components on buprenorphine treatment retention at six months will be tested by recruiting persons initiating buprenorphine from office-based addiction treatment settings and randomizing them in a balanced 2x2x2 factorial design to some combination of the following 3 intervention components:

1. Behavioral-Activation (BA)-focused on increasing positive reinforcing activities and experiences to promote recovery;
2. Attendance Reinforcement (AR)- incentivizing attendance at addiction clinical care visits; and
3. Peer Motivational Interviewing (Peer-MI) -increasing confidence to continue buprenorphine treatment and providing social support.

All participants will receive usual care, including brief advice to continue treatment for at least 6 months.

The observed main and interaction effects for the 3 candidate psychosocial interventions will guide the selection of components to be included in an optimized intervention (the end goal of this project).

Results from this study will be twofold:

1. improve the understanding of mechanisms by which psychosocial component interventions improve buprenorphine MOUD treatment retention, and
2. prepare the scientific team to conduct a future randomized controlled trial of the optimized intervention package.

The long-term impact will be to establish a psychosocial intervention package that improves retention in buprenorphine treatment.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Stein, MD; Phone Number: (617) 638-5042; Email: mdstein@bu.edu
• Study Contact Backup: Name: Sally Bendiks, MPH; Phone Number: (617) 414-3802; Email: Sally.Bendiks@bmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

-Be receiving hospice or other end of life medical care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Activation; Participants in this arm will receive the behavioral activation intervention.	Behavioral: Behavioral Activation (BA); 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.
Experimental: Attendance Reinforcement; Participants in this arm will receive the Attendance Reinforcement intervention.	Behavioral: Attendance Reinforcement (AR); 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).
Experimental: Peer-Delivered Motivational Interviewing; Participants in this arm will receive the Peer-Delivered Motivational Interviewing Intervention.	Behavioral: Peer-Delivered Motivational Interviewing (PDMI); 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.
Experimental: Behavioral Activation + Attendance Reinforcement; Participants in this arm will receive the Behavioral Activation and Attendance Reinforcement interventions.	Behavioral: Behavioral Activation (BA); 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: Attendance Reinforcement (AR); 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).
Experimental: Behavioral Activation + Peer-Delivered Motivational Interviewing; Participants in this arm will receive the Behavioral Activation and Peer-Delivered Motivational Interviewing interventions.	Behavioral: Behavioral Activation (BA); 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: Peer-Delivered Motivational Interviewing (PDMI); 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.
Experimental: Attendance Reinforcement + Peer-Delivered Motivational Interviewing; Participants in this arm will receive the Attendance Reinforcement and Peer-Delivered Motivational Interviewing interventions.	Behavioral: Peer-Delivered Motivational Interviewing (PDMI); 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.; Behavioral: Attendance Reinforcement (AR); 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).
Experimental: Behavioral Activation + Attendance Reinforcement + Peer-Delivered Motivational Interviewing; Participants in this arm will receive the Behavioral Activation, Attendance Reinforcement, and Peer-Delivered Motivational Interviewing interventions.	Behavioral: Behavioral Activation (BA); 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: Peer-Delivered Motivational Interviewing (PDMI); 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.; Behavioral: Attendance Reinforcement (AR); 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).
No Intervention: Treatment As Usual; Participants randomized to this arm will receive usual care at their office based addiction treatment facility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Michael Stein, MD, BUSPH, Health Law, Policy & Management

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Buprenorphine; Behavioral activation; Multiphase Optimization STrategy (MOST); Attendance reinforcement; Peer motivational interviewing
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: H-46388; R01DA062408 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No