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

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Boston University

Status

Begins enrollment this month

Conditions

Opioid Use Disorder

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07607743
R01DA062408 (U.S. NIH Grant/Contract)
H-46388

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

240 participants in 8 patient groups

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

Trial contacts and locations

0

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Central trial contact

Michael Stein, MD; Sally Bendiks, MPH

Data sourced from clinicaltrials.gov

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