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

Официальное название

BUP-BOOSTeR: Behavioral Optimization for Overcoming Suboptimal Treatment Retention

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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).
• Поведенческое 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

Первичные конечные точки

• Number of participants with buprenorphine retention [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

-Be receiving hospice or other end of life medical care

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07607743 · H-46388 · R01DA062408

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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