Cognitive-enhancing DA Medications for Cocaine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Cocaine Use Based on Urine Drug Screening
研究概览
简要总结
The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet criteria for cocaine dependence
- •seeking treatment for cocaine dependence
- •be in acceptable health based on medical history and physical exam
排除标准
- •dependent on drugs other than cocaine, nicotine, marijuana
- •have a medical condition contraindicating treatment with study medications
- •having conditions of probation or parole requiring reports of drug use to officers of the court
研究组 & 干预措施
ldopa + ropinirole low dose
levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d
干预措施: levodopa/carbidopa (Drug)
ldopa + ropinirole low dose
levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d
干预措施: Ropinirole 2 mg/d (Drug)
ldopa + ropinirole high dose
levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d
干预措施: levodopa/carbidopa (Drug)
ldopa + ropinirole high dose
levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d
干预措施: Ropinirole 4 mg/d (Drug)
ldopa
levodopa/carbidopa 800/200 mg/d
干预措施: levodopa/carbidopa (Drug)
placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cocaine Use Based on Urine Drug Screening
时间窗: 10 weeks
The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol.
次要结局
- Number of Participants Who Completed the 10 Week Trial(10 weeks)
研究者
Joy Schmitz
Professor - Psychiatry
The University of Texas Health Science Center, Houston