Behavioral Optimization for Overcoming Suboptimal Treatment Retention (BUP-BOOSTeR) (BUP-BOOSTeR)
24 maja 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
240
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Michael Stein, MD
- Numer telefonu: (617) 638-5042
- E-mail: mdstein@bu.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Sally Bendiks, MPH
- Numer telefonu: (617) 414-3802
- E-mail: Sally.Bendiks@bmc.org
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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).
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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).
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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).
|
|
Eksperymentalny: 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).
|
|
Brak interwencji: Treatment As Usual
Participants randomized to this arm will receive usual care at their office based addiction treatment facility.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of participants with buprenorphine retention
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Michael Stein, MD, BUSPH, Health Law, Policy & Management
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 września 2026
Zakończenie podstawowe (Szacowany)
1 grudnia 2029
Ukończenie studiów (Szacowany)
1 grudnia 2029
Daty rejestracji na studia
Pierwszy przesłany
21 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
21 maja 2026
Pierwszy wysłany (Rzeczywisty)
26 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
28 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- H-46388
- R01DA062408 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .