Testing the Effects of Contingency Management and Behavioral Economics on Buprenorphine-Naloxone Treatment Adherence Using a Sequential Multiple Assignment Randomized Trial (SMART) Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Medication-Assisted Treatment (MAT) Adherence
研究概览
简要总结
The purpose of this study is to compare the effectiveness of two different interventions for medication-assisted treatment (MAT) adherence: Contingency Management (CM) and Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM).
详细描述
The investigators seek to compare the effectiveness of these two different interventions for MAT adherence by first refining and piloting CM and BSM adherence approaches, then conducting a Sequential Multiple Assignment Randomized Trial (SMART) to assess sequential, individual, and combined effects across MAT initiation and maintenance.
In order to tailor treatment to individual's needs, the study will follow a sequential multiple assignment randomized trial (SMART) design: In stage 1, participants are individually randomized (1:1) to BSM or CM. Adherent buprenorphine-naloxone participants complete treatment in the arm they were originally assigned to, but non-adherent participants are re-randomized (1:1) to either switch to the other intervention or add the other intervention in this part-factorial SMART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Present with symptoms of Opioid Use Disorder
- •Eligible of receipt of buprenorphine-naloxone medication as determined by Study Doctor
- •Access to a telephone
排除标准
- •Under 18 years old
- •Unable to understand spoken English
研究组 & 干预措施
Contingency Management (CM)
CM is a behavioral method that employs external rewards for target behavior. Participants will receive gift cards for adhering to treatment (attending physician visits and being adherent to buprenorphine-naloxone) for their first 4 clinic visits.
干预措施: Contingency Management (Behavioral)
Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM)
Participants will receive the BSM intervention at 4 timepoints.
干预措施: Brief Motivational Interviewing + Substance Free Activities + Mindfulness (Behavioral)
BSM+CM
BSM+CM is a combination of the two other arms. Participants may be randomized to this arm only in stage 2 of the SMART design.
干预措施: Contingency Management (Behavioral)
BSM+CM
BSM+CM is a combination of the two other arms. Participants may be randomized to this arm only in stage 2 of the SMART design.
干预措施: Brief Motivational Interviewing + Substance Free Activities + Mindfulness (Behavioral)
结局指标
主要结局
Medication-Assisted Treatment (MAT) Adherence
时间窗: through study completion, an average of 8 months
Number of visits where participant attends physician appointment and drug screen results are buprenorphine-positive.
次要结局
未报告次要终点
研究者
Karen Derefinko, PhD
Assistant Professor
University of Tennessee