Behavioral Optimization for Overcoming Suboptimal Treatment Retention (BUP-BOOSTeR) (BUP-BOOSTeR)
2026年5月24日 更新者：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.
研究概览
地位
尚未招聘
条件
详细说明
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.
研究类型
介入性
注册 (估计的)
240
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Michael Stein, MD
- 电话号码：(617) 638-5042
- 邮箱：mdstein@bu.edu
研究联系人备份
- 姓名：Sally Bendiks, MPH
- 电话号码：(617) 414-3802
- 邮箱：Sally.Bendiks@bmc.org
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
|
实验性的：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).
|
|
实验性的：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.
|
|
实验性的：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).
|
|
实验性的：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.
|
|
实验性的：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).
|
|
实验性的：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).
|
|
无干预：Treatment As Usual
Participants randomized to this arm will receive usual care at their office based addiction treatment facility.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants with buprenorphine retention
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michael Stein, MD、BUSPH, Health Law, Policy & Management
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2029年12月1日
研究完成 (估计的)
2029年12月1日
研究注册日期
首次提交
2026年5月21日
首先提交符合 QC 标准的
2026年5月21日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年5月28日
上次提交的符合 QC 标准的更新
2026年5月24日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- H-46388
- R01DA062408 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.