A Method to Increase Buprenorphine Treatment Capacity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CBT4CBT, LLC
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Percent of urine toxicology screens that are negative for opioids by group.
研究概览
简要总结
In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a larger and diverse population of individuals seeking buprenorphine treatment in primary care (N=100).
详细描述
In this phase, 100 individuals entering buprenorphine maintenance at the primary care clinic (Central Medical Unit, CMU) will be randomized to either (1) standard buprenorphine maintenance in which counseling is offered on site, or (2) standard buprenorphine maintenance with CBT4CBT-Buprenorphine substituting for on-site counseling. This will be a 12-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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets current Diagnostic Statistical Manual (DSM-5) criteria for opioid use disorder
- •Requesting buprenorphine maintenance treatment at Central Medical Unit of the APT Foundation
排除标准
- •Unstabilized psychotic disorder
- •Currently suicidal or homicidal
- •Current cocaine, benzodiazepine, or alcohol use disorder.
- •Any history of PCP (phencyclidine) use.
- •Pregnant or lactating
- •Any other physical or mental condition that would contraindicate office-based buprenorphine maintenance treatment.
研究组 & 干预措施
Standard Buprenorphine
Participants assigned to this arm will received buprenorphine treatment consistent with standard practice at the study site. This includes induction by a physician, regular meetings with a physician for medical management, urine monitoring, and prescription of buprenorphine, with access to behavioral support services.
干预措施: Buprenorphine/naloxone (Drug)
Standard Buprenorphine plus CBT4CBT-Buprenorphine
Participants in this condition will receive Standard Buprenorphine as described above, with the addition of access to the CBT4CBT-Buprenorphine program, which is a web-based program that covers basic knowledge about buprenorphine treatment as well as teaches cognitive and behavioral coping skills.
干预措施: CBT4CBT-Buprenorphine (Behavioral)
Standard Buprenorphine plus CBT4CBT-Buprenorphine
Participants in this condition will receive Standard Buprenorphine as described above, with the addition of access to the CBT4CBT-Buprenorphine program, which is a web-based program that covers basic knowledge about buprenorphine treatment as well as teaches cognitive and behavioral coping skills.
干预措施: Buprenorphine/naloxone (Drug)
结局指标
主要结局
Percent of urine toxicology screens that are negative for opioids by group.
时间窗: 12 weeks
Percent of urine toxicology screens, collected weekly, that are negative for opioid metabolites.
次要结局
未报告次要终点