NCT00033046Unknown1 期
Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- pharmacokinetic parmaters at steady state
研究概览
简要总结
The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.
详细描述
Placebo-controlled, escalating dose drug interaction study using a total of 12 cocaine users at a single site. Study duration will include four infusion sessions: 1) screening/baseline; 2) baseline; 3) 400mg/day steady-state modafinil; 4) 800 mg/day steady state modafinil. Infusion session will be 2 days in duration.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dependent on cocaine; non-treatment seeking; male or female; DSM-4 criteria for cocaine abuse or dependence; at least 18 years of age but no older than 45 non-pregnant females using adequate birth control; capable of providing written informed consent; able to comply with protocol requirements.
排除标准
- •Additional criteria available during screening at the site
结局指标
主要结局
pharmacokinetic parmaters at steady state
BP, HR
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Modafinil for the Treatment of Cocaine Dependence - 1Cocaine-Related DisordersNCT00100100National Institute on Drug Abuse (NIDA)210
已完成
2 期
Modafinil Treatment for Cocaine Dependence and HIV High-Risk BehaviorCocaine DependenceNCT00368290Kyle Kampman94
已完成
1 期
Pharmacotherapy & CM for Opioid and Cocaine DependenceCocaine DependenceNCT00838981Yale University91
已完成
1 期
Cocaine-Methylphendidate Interaction Study - 4Cocaine-Related DisordersNCT00015067National Institute on Drug Abuse (NIDA)8
已完成
1 期
Modafinil - Escitalopram Study for Cocaine DependenceCocaine DependenceCocaine AbuseCocaine AddictionSubstance AbuseNCT01601730Baylor College of Medicine68