BUP-BOOSTeR: Behavioral Optimization for Overcoming Suboptimal Treatment Retention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Number of participants with buprenorphine retention
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 析因
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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
排除标准
- Be receiving hospice or other end of life medical care
研究组 & 干预措施
Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Peer-Delivered Motivational Interviewing Intervention.
干预措施: Peer-Delivered Motivational Interviewing (PDMI) (Behavioral)
Behavioral Activation + Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Behavioral Activation and Peer-Delivered Motivational Interviewing interventions.
干预措施: Peer-Delivered Motivational Interviewing (PDMI) (Behavioral)
Attendance Reinforcement + Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Attendance Reinforcement and Peer-Delivered Motivational Interviewing interventions.
干预措施: Attendance Reinforcement (AR) (Behavioral)
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.
干预措施: Attendance Reinforcement (AR) (Behavioral)
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.
干预措施: Peer-Delivered Motivational Interviewing (PDMI) (Behavioral)
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.
干预措施: Behavioral Activation (BA) (Behavioral)
Attendance Reinforcement
Participants in this arm will receive the Attendance Reinforcement intervention.
干预措施: Attendance Reinforcement (AR) (Behavioral)
Behavioral Activation + Attendance Reinforcement
Participants in this arm will receive the Behavioral Activation and Attendance Reinforcement interventions.
干预措施: Behavioral Activation (BA) (Behavioral)
Behavioral Activation + Attendance Reinforcement
Participants in this arm will receive the Behavioral Activation and Attendance Reinforcement interventions.
干预措施: Attendance Reinforcement (AR) (Behavioral)
Behavioral Activation
Participants in this arm will receive the behavioral activation intervention.
干预措施: Behavioral Activation (BA) (Behavioral)
Behavioral Activation + Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Behavioral Activation and Peer-Delivered Motivational Interviewing interventions.
干预措施: Behavioral Activation (BA) (Behavioral)
Attendance Reinforcement + Peer-Delivered Motivational Interviewing
Participants in this arm will receive the Attendance Reinforcement and Peer-Delivered Motivational Interviewing interventions.
干预措施: Peer-Delivered Motivational Interviewing (PDMI) (Behavioral)
Treatment As Usual
Participants randomized to this arm will receive usual care at their office based addiction treatment facility.
结局指标
主要结局
Number of participants with buprenorphine retention
时间窗: 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
次要结局
未报告次要终点
研究者
标识符
- NCT 编号
- NCT07607743
- 其他研究编号
- H-46388, R01DA062408
日期
- 首次提交
- (4个月前)
- 首次发布
- (4个月前)
- 主要完成日期
- (3年后)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否