Novel Pharmacotherapy for Dual Dependence
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The topiramate group will be superior to the placebo group on the following outcome measures:increasing the weekly mean proportion of cocaine-free days, decreasing self-reported drinking, and decreasing craving for cocaine and alcohol.
研究概览
简要总结
The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence.
详细描述
Our objective is to understand the basic mechanisms that underpin substance dependence, and to develop efficacious treatments for individuals with comorbid cocaine and alcohol dependence.
Participants in this study will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks.Follow-up visits will occur at 2 weeks and 1,2,, and 3 months following completion of 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
- 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
- •Subjects will be men and women between the ages of 18 years and older.
- •Must meet at least three of the seven DSM IV diagnostic criteria for alcohol and cocaine dependence.
- •Express a desire for treatment.
- •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 are required.
- •Prospective subjects must report cocaine use of at least once per month and alcohol consumption of ≥21 drinks/week and ≥14 drinks/week for men and women respectively, during the past 30 days
- •At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.
排除标准
- •Please contact site for additional information
研究组 & 干预措施
Topiramate
Topiramate + Cognitive Behavioral Therapy
干预措施: Topiramate + Cognitive Behavioral Therapy (Drug)
Placebo
Placebo + Cognitive Behavioral Therapy
干预措施: Placebo + Cognitive Behavioral Therapy (Drug)
结局指标
主要结局
The topiramate group will be superior to the placebo group on the following outcome measures:increasing the weekly mean proportion of cocaine-free days, decreasing self-reported drinking, and decreasing craving for cocaine and alcohol.
时间窗: According to Preston Rules from weeks 6 to 12.
Alcohol - assessed by self-report of use (TLFB,DD,DDD,PDA, PHDD), biochemical markers (GGT, CDT), OCDS Cocaine - assessed by self-report of use (CTFB, substance use inventory, QFI),urine assay for benzoylecgonine, and CCQ-NOW
次要结局
- a. Cocaine free weeks; b. Topiramate, compared with placebo, will be associated with an improvement in psychosocial functioning as exemplified by improved general well-being, social functioning, and quality of life.(According to Preston Rules from weeks 1 to 12)
研究者
Bankole Johnson
Chair of Psychiatry and Neurobehavioral Sciences
University of Virginia