Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sharon Walsh
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- % Urine Samples Negative for Cocaine
研究概览
简要总结
This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Seeking treatment for cocaine dependence
- •Must have used cocaine in the past 30 days
排除标准
- •Physical dependence on any drug requiring medical management
- •Any major medical or psychiatric disorder that would be contraindicated for participation
- •Cardiovascular disease
- •Seizures or significant head injuries
- •Currently taking atomoxetine
- •Pregnant or breast-feeding
研究组 & 干预措施
1
Atomoxetine
干预措施: atomoxetine (Drug)
2
Matched Placebo
干预措施: placebo (Drug)
结局指标
主要结局
% Urine Samples Negative for Cocaine
时间窗: Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks
Total % urine samples negative for benzoylecgonine over the 12-week trial
次要结局
- Retention(12-weeks)
研究者
Sharon Walsh
Director Center on Drug and Alcohol Research
University of Kentucky