Opioid Use DisorderBUP-BOOSTeRNCT07607743
Behavioral Optimization for Overcoming Suboptimal Treatment Retention (BUP-BOOSTeR)
A study testing Behavioral Activation (BA), Attendance Reinforcement (AR) and Peer-Delivered Motivational Interviewing (PDMI) in people with Opioid Use Disorder, run by Boston University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Behavioral Activation (BA), Attendance Reinforcement (AR) and Peer-Delivered Motivational Interviewing (PDMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Be receiving hospice or other end of life medical care
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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:
- Behavioral-Activation (BA)-focused on increasing positive reinforcing activities and experiences to promote recovery;
- Attendance Reinforcement (AR)- incentivizing attendance at addiction clinical care visits; and
- 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:
- improve the understanding of mechanisms by which psychosocial component interventions improve buprenorphine MOUD treatment retention, and
- 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Behavioral Activation (BA), Attendance Reinforcement (AR), Peer-Delivered Motivational Interviewing (PDMI)
- Keywords
- Behavioral activation, Attendance reinforcement, Peer motivational interviewing, Multiphase Optimization STrategy (MOST), Buprenorphine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation (BA)Behavioural
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.
Attendance Reinforcement (AR)Behavioural
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).
Peer-Delivered Motivational Interviewing (PDMI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation | Experimental | Participants in this arm will receive the behavioral activation intervention. Receives: Behavioral: Behavioral Activation (BA) |
| Attendance Reinforcement | Experimental | Participants in this arm will receive the Attendance Reinforcement intervention. Receives: Behavioral: Attendance Reinforcement (AR) |
| Peer-Delivered Motivational Interviewing | Experimental | Participants in this arm will receive the Peer-Delivered Motivational Interviewing Intervention. Receives: Behavioral: Peer-Delivered Motivational Interviewing (PDMI) |
| Behavioral Activation + Attendance Reinforcement | Experimental | Participants in this arm will receive the Behavioral Activation and Attendance Reinforcement interventions. Receives: 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Michael Stein, MD, Principal investigator, BUSPH, Health Law, Policy & Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607743
- Sponsor's protocol ID
- H-46388
- Other IDs
- R01DA062408
- Acronym
- BUP-BOOSTeR
- Status last verified
- Sep 2026
- First submitted
- 21 May 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BUP-BOOSTeR: Behavioral Optimization for Overcoming Suboptimal Treatment Retention
- ClinicalTrials.gov ID
- NCT07607743
- Acronym / sponsor ID
- BUP-BOOSTeR / H-46388
- Conditions
- Opioid Use Disorder
- Keywords
- Behavioral activation, Attendance reinforcement, Peer motivational interviewing, Multiphase Optimization STrategy (MOST), Buprenorphine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Behavioral-Activation (BA)-focused on increasing positive reinforcing activities and experiences to promote recovery;
- Attendance Reinforcement (AR)- incentivizing attendance at addiction clinical care visits; and
- 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:
- improve the understanding of mechanisms by which psychosocial component interventions improve buprenorphine MOUD treatment retention, and
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral: Behavioral Activation (BA)Participants in this arm will receive the behavioral activation intervention. |
| Attendance Reinforcement | Experimental | Behavioral: Attendance Reinforcement (AR)Participants in this arm will receive the Attendance Reinforcement intervention. |
| Peer-Delivered Motivational Interviewing | Experimental | Behavioral: Peer-Delivered Motivational Interviewing (PDMI)Participants in this arm will receive the Peer-Delivered Motivational Interviewing Intervention. |
| Behavioral Activation + Attendance Reinforcement | Experimental | Behavioral: Behavioral Activation (BA), Behavioral: Attendance Reinforcement (AR)Participants in this arm will receive the Behavioral Activation and Attendance Reinforcement interventions. |
| Behavioral Activation + Peer-Delivered Motivational Interviewing | Experimental | Behavioral: Behavioral Activation (BA), Behavioral: Peer-Delivered Motivational Interviewing (PDMI)Participants in this arm will receive the Behavioral Activation and Peer-Delivered Motivational Interviewing interventions. |
| Attendance Reinforcement + Peer-Delivered Motivational Interviewing | Experimental | Behavioral: Attendance Reinforcement (AR), Behavioral: Peer-Delivered Motivational Interviewing (PDMI)Participants in this arm will receive the Attendance Reinforcement and Peer-Delivered Motivational Interviewing interventions. |
| Behavioral Activation + Attendance Reinforcement + Peer-Delivered Motivational Interviewing | Experimental | Behavioral: Behavioral Activation (BA), Behavioral: Attendance Reinforcement (AR), Behavioral: Peer-Delivered Motivational Interviewing (PDMI)Participants in this arm will receive the Behavioral Activation, Attendance Reinforcement, and Peer-Delivered Motivational Interviewing interventions. |
| Treatment As Usual | No intervention | –Participants randomized to this arm will receive usual care at their office based addiction treatment facility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- -Be receiving hospice or other end of life medical care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Behavioral Activation, Behavioral Activation + Attendance Reinforcement, Behavioral Activation + Attendance Reinforcement + Peer-Delivered Motivational Interviewing, Behavioral Activation + Peer-Delivered Motivational Interviewing |
| 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). | Behavioural | 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)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. | Behavioural | Attendance Reinforcement + Peer-Delivered Motivational Interviewing, Behavioral Activation + Attendance Reinforcement + Peer-Delivered Motivational Interviewing, Behavioral Activation + Peer-Delivered Motivational Interviewing, Peer-Delivered Motivational Interviewing |
Primary outcome
Number of participants with buprenorphine retention
Time frame: 6 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Stein, MD principal investigator
BUSPH, Health Law, Policy & Management
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation (BA), Attendance Reinforcement (AR) and Peer-Delivered Motivational Interviewing (PDMI) in people with Opioid Use Disorder, run by Boston University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Stein, MD ((617) 638-5042, mdstein@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with buprenorphine retention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.