New Medication Treatment for Stimulant Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Cocaine Use by Self-report
研究概览
简要总结
This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.
详细描述
We propose to conduct a 9 week randomized, controlled clinical trial to evaluate the efficacy of ondansetron 4 mg twice daily compared with placebo (total N = 100/group × 2 groups = 200 individuals randomized, 400 total subjects will be consented), provided as an adjunct to manual-driven, structured CBT + BBCET in the treatment of cocaine dependence.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females who have given written informed consent.
- •Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg.
- •Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
- •Current DSM-IV diagnosis of cocaine dependence.
- •At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.
- •The pregnancy test for females at intake must be negative.
- •Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
- •Answered an advertisement in the newspaper/radio/television, and expressing a wish to stop using cocaine.
- •Willing to participate in behavioral treatments for cocaine dependence.
排除标准
- •Please contact site for additional information
研究组 & 干预措施
Ondansetron
Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
干预措施: Ondansetron (Drug)
Placebo
Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
干预措施: Placebo (Drug)
结局指标
主要结局
Cocaine Use by Self-report
时间窗: up to 9 weeks
Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report
Cocaine Use by Urine Benzoylecgonine
时间窗: up to 9 weeks
Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine
次要结局
未报告次要终点
研究者
Nassima Ait-Daoud Tiouririne
Associate Professor, Director of UVA Center for Addiction Research and Education
University of Virginia