Pharmacotherapy for Cocaine Dependence - 1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Substance use and retention
研究概览
简要总结
Dextro-amphetamine sulfate is a central nervous system stimulant that increases the release of the neurotransmitter dopamine in the brain. The purpose of this study is to further examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence.
详细描述
This randomized, double-blind dose study will compare the effectiveness of three active medication doses of dextro-amphetamine sulfate to placebo in the treatment of cocaine dependence. Participants will be randomly assigned to one of the four following dosages of dextro-amphetamine sulfate: 0 mg, 40 mg, 60 mg, or 80 mg. Participants will undergo a 2-week stabilization period followed by a 25-week study period. The study period will include administration of the stable medication dose for 21 weeks, followed by 1 week of dose reduction, and then 3 weeks without medication. All participants will receive weekly cognitive behavioral therapy and electrocardiograms. Participants will be given the option to participate in a voluntary plasma blood draw during Weeks 4, 8, and 20 and will be scheduled for follow-up assessments at Months 1 and 3 post-treatment.
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
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of cocaine dependence, as determined by the Structured Clinical Interview for DSM-IV
- •Agreement to use an adequate method of contraception for the duration of the study
- •Electrocardiogram confirmation by a cardiologist
- •Cocaine-positive urine test prior to study entry
排除标准
- •High blood pressure
- •Significant heart disease
- •Clinically significant cardiovascular abnormality
- •Kidney, liver, or gastrointestinal disorder
- •Current Axis I disorder not related to drug use
- •Current dependence on any drug other than nicotine
- •Attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD)
- •On probation or parole for reasons other than those related to drug abuse charges
- •Pregnant or breastfeeding
- •Sought treatment for drug dependence within 3 months prior to study entry
- •Currently taking prescribed medications
结局指标
主要结局
Substance use and retention
次要结局
- Effectiveness measures, including psycho-social variables, side effects, and self-reported measures
研究者
Joy Schmitz
Professor - Psy, Behavioral Science
The University of Texas Health Science Center, Houston