Clinical Trial of Serotonin Medication Combination in Cocaine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test
研究概览
简要总结
This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent patients will be assigned equally to one of three medication conditions: placebo or the Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or 40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase periods of sustained abstinence substantially more than placebo. Performance on a set of behavioral tasks of impulsivity will be analyzed as potential predictors of treatment response.
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
- Triple (Participant, 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
- 否
入选标准
- •between 18 and 60 years of age
- •meet Diagnostic and Statistical Manual 4 (DSM-IV) criteria for current cocaine dependence
- •be in acceptable health on the basis of interview, medical history and physical exam
- •able to provide the names of at least 2 persons who can generally locate their whereabouts.
排除标准
- •diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine
- •have a psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
- •medical conditions contraindicating citalopram pharmacotherapy
- •taking medications known to have significant drug interactions with the study medication
- •pregnant or nursing for female patients
- •having plans to leave the immediate geographical area within 3 months
研究组 & 干预措施
Citalopram low dose
Citalopram 20 mg
干预措施: Citalopram (Drug)
Citalopram high dose
Citalopram 40 mg
干预措施: Citalopram (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test
时间窗: 9 weeks
Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.
次要结局
- Proportion of Cocaine-positive Urines Per Week(9 weeks)
- Retention as Assessed by Number of Participants Remaining in Treatment(9 weeks)
- Number of Participants With Cocaine-negative Urines Collected During Treatment Period(9 weeks)
研究者
Joy Schmitz
Professor , Behavioral Sciences
The University of Texas Health Science Center, Houston