Cocaine Use Reduction With Buprenorphine (CURB)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 11
- 主要终点
- Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens
研究概览
简要总结
The aim of this study is to investigate the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence.
详细描述
This project will assess the utility of buprenorphine in the presence of naltrexone as a potential medication useful in reducing cocaine use, commencing a research direction of great importance to both theoretical and practical addiction medicine. Buprenorphine will be provided as sublingual buprenorphine+naloxone tablets (Suboxone®, "BUP"). Naltrexone will be provided as extended-release (XR) naltrexone by injection (Vivitrol®, "XR-NTX").
In this multi-center, double-blind, placebo-controlled trial, participants will randomly assigned to one of three medication conditions: 4mg buprenorphine plus naltrexone (BUP4+XR-NTX), 16mg buprenorphine plus naltrexone (BUP16+XR-NTX), or placebo plus naltrexone (PLB+XR-NTX) for 8 weeks of treatment. Participants will be scheduled for clinic visits three times weekly (for a total of 24 visits across the 8-week treatment period) for observed medication administration, provision of take-home medication, collection of safety, medical, drug use, psychological, and compliance measures. In addition, all participants will be scheduled for once-weekly individual Cognitive Behavioral Therapy (CBT) sessions.
This protocol will explore the effects of these three medication conditions to test buprenorphine as a possible treatment for cocaine dependence. This study will advance the science, provide dosing information, and characterize the effects of the combination of the two medications in this population.
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
- Double (Participant, Investigator)
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
- •18 to 65 years of age
- •In good general health
- •Meet Diagnostic and Statistical Manual (DSM)-IV criteria for cocaine dependence
- •Meet DSM-IV criteria for past-year opioid dependence OR past-year opioid abuse OR have past-year opioid use and a history of opioid dependence during the lifetime
- •Interested in receiving treatment for cocaine dependence
- •Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
- •Able to satisfy and comply with study procedures and requirements
- •If female of childbearing potential, willing to practice and effective method of birth control for the duration of the study
排除标准
- •Pregnant or breastfeeding females
- •Known allergy or sensitivity to study medications
- •Recent or ongoing treatment with medications that, in the judgment of the study medical clinician, could interact adversely with study drugs or interfere with study participation
- •Have a current pattern of alcohol, benzodiazepine, or other sedative-hypnotic use, as determined by the study medical clinician, which would preclude safe participation
- •Liver function test results greater than 5 times the upper limit of normal or other exclusionary clinical lab test values
- •Serious medical condition or acute psychiatric disorder that would make study participation difficult or unsafe
- •Pending action or situation that might prevent remaining in the area for the duration of the study
研究组 & 干预措施
BUP4+XR-NTX
4mg buprenorphine plus naltrexone for 8 weeks of treatment
干预措施: Buprenorphine + Naltrexone (Drug)
BUP16+XR-NTX
16mg buprenorphine plus naltrexone for 8 weeks of treatment
干预措施: Buprenorphine + Naltrexone (Drug)
PLB+XR-NTX
naltrexone for 8 weeks of treatment
干预措施: Placebo + Naltrexone (Drug)
结局指标
主要结局
Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens
时间窗: final 30 days of Treatment Phase, study days 25-54
Self-reported days of cocaine use corroborated with urine drug screens (UDS).
次要结局
未报告次要终点