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

24. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

240

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Michael Stein, MD
  • Telefonnummer: (617) 638-5042
  • E-Mail: mdstein@bu.edu

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Behavioral Activation
Participants in this arm will receive the behavioral activation intervention.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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).
Kein Eingriff: Treatment As Usual
Participants randomized to this arm will receive usual care at their office based addiction treatment facility.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants with buprenorphine retention
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boston University

Mitarbeiter

National Institute on Drug Abuse (NIDA)

Ermittler

  • Hauptermittler: Michael Stein, MD, BUSPH, Health Law, Policy & Management

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2029

Studienabschluss (Geschätzt)

1. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

21. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Mai 2026

Zuerst gepostet (Tatsächlich)

26. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H-46388
  • R01DA062408 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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