Lisdexamfetamine Treatment for Cocaine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Cocaine-positive Urine Results
研究概览
简要总结
This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.
详细描述
This 2-group, double-blind, placebo-controlled, 14-week study (N=100) will investigate the efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine dependence. We hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome), as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants must:
- •Be treatment-seeking males or females between 18 and 65 years-of-age;
- •Understand the study procedures and provide written informed consent;
- •Be judged by the examining physician to be in generally good health with the exception of health problems related to acute drug use;
- •Meet DSM-IV criteria for cocaine-dependence.
排除标准
- •Exclusion criteria include:
- •DSM-IV diagnoses for current psychotic disorders, mood disorders (except substance-induced depression), anxiety disorders, ADHD, and other current substance dependence (except marijuana and nicotine dependence); subjects may not have physiological dependence upon alcohol requiring medical detoxification;
- •Current use of any prescription medications;
- •Females currently pregnant or nursing;
- •Current elevation of liver enzyme levels above twice normal limits;
- •Existing cardiovascular disease as determined by physician, EKG evaluation;
- •History of significant acute or chronic physical illness precluding participation;
- •History of hyperthyroidism, glaucoma, or seizures.
研究组 & 干预措施
lisdexamfetamine/Behavior Therapy
lisdexamfetamine 70mg/day plus Behavior Therapy
干预措施: lisdexamfetamine/Behavior Therapy (Drug)
placebo
Placebo Comparator once per day
干预措施: placebo (Other)
结局指标
主要结局
Cocaine-positive Urine Results
时间窗: 14 Weeks
At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL.
次要结局
- Drug Craving(14 Weeks)