Integrated Intervention Combining CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in drug use
研究概览
简要总结
To conduct an 8-week pilot, randomized trial evaluating the feasibility, acceptability, and efficacy of an integrated intervention involving CBT4CBT-Buprenorphine + Recovery Coach in a population of 60 individuals who meet current DSM criteria for opioid use disorder and are receiving buprenorphine treatment in primary care.
详细描述
In this pilot study, 50 individuals with OUD on buprenorphine will be randomized to either 1) standard of care (N=25) or (2)CBT4CBT-Buprenorphine + Recovery Coach (N=250). This will be an 8-week trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults (≥18 years)
- •having a DSM-V diagnosis of OUD
- •sublingual buprenorphine/naloxone and/or buprenorphine
- •having initiated maintenance treatment for OUD for at least 30 days before the screening
- •self-report or toxicology screening positive for any substance within 30 days of screening;
- •willing to accept a random assignment to either TAU/CBT4CBT-Buprenorphine + Recovery Coach;
- •having adequate computer skills
排除标准
- •having a severe medical or psychiatric disability that could impair their ability to perform study-related activities (determined by the clinician)
- •being pregnant or breastfeeding;
- •being unable to independently read and/or comprehend the consent form or other study materials
- •being unable to read/speak English;
- •having current suicidal ideation based on the Patient Health Questionnaire-9.
研究组 & 干预措施
Standard Treatment As Usual (TAU)
Participants in the standard of care condition will receive the standard treatment at the recovery program, which consists of weekly or bi-weekly visits (at the discretion of the provider) to the clinic to meet with their provider and provide a sample of blood.
CBT4CBT-Buprenorphine + Recovery Coach
This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professional
干预措施: CBT4CBT-Buprenorphine + Recovery Coach (Behavioral)
结局指标
主要结局
Change in drug use
时间窗: 0-8 weeks
Using saliva toxicology tests
次要结局
- Retention to buprenorphine(3 month follow up)
- Change in drug use(1 and 3 month follow up)