Behavioral Optimization for Overcoming Suboptimal Treatment Retention (BUP-BOOSTeR) (BUP-BOOSTeR)
24. mai 2026 oppdatert av: Boston University
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
240
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Michael Stein, MD
- Telefonnummer: (617) 638-5042
- E-post: mdstein@bu.edu
Studer Kontakt Backup
- Navn: Sally Bendiks, MPH
- Telefonnummer: (617) 414-3802
- E-post: Sally.Bendiks@bmc.org
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Behavioral Activation
Participants in this arm will receive the behavioral activation intervention.
|
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.
|
|
Eksperimentell: Attendance Reinforcement
Participants in this arm will receive the Attendance Reinforcement intervention.
|
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).
|
|
Eksperimentell: Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Peer-Delivered Motivational Interviewing Intervention.
|
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.
|
|
Eksperimentell: Behavioral Activation + Attendance Reinforcement
Participants in this arm will receive the Behavioral Activation and Attendance Reinforcement interventions.
|
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.
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).
|
|
Eksperimentell: Behavioral Activation + Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Behavioral Activation and Peer-Delivered Motivational Interviewing interventions.
|
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.
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.
|
|
Eksperimentell: Attendance Reinforcement + Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Attendance Reinforcement and Peer-Delivered Motivational Interviewing interventions.
|
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.
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).
|
|
Eksperimentell: 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.
|
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.
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.
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).
|
|
Ingen inngripen: Treatment As Usual
Participants randomized to this arm will receive usual care at their office based addiction treatment facility.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with buprenorphine retention
Tidsramme: 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
|
6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michael Stein, MD, BUSPH, Health Law, Policy & Management
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. desember 2029
Studiet fullført (Antatt)
1. desember 2029
Datoer for studieregistrering
Først innsendt
21. mai 2026
Først innsendt som oppfylte QC-kriteriene
21. mai 2026
Først lagt ut (Faktiske)
26. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-46388
- R01DA062408 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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