Combining Medications Treatment for Alcoholism
试验速览
- 阶段
- 2 期
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
研究概览
简要总结
The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
详细描述
This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. There is a 1, 2, and 3 month post-study follow up visit. Screening for this study is initially done over the telephone and takes 15-20 minutes. If there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Current diagnosis of alcohol dependence and drinking greater than or equal to 14 alcohol drinks/week for women and greater than or equal to 21 alcohol drinks/week for men in the last 30 days.
- •Provide a written, informed consent.
- •Good physical health and must weigh within at least 40 kg and no more than 140 kg.
- •Literate in English and able to read, understand, follow instructions, and complete questionnaires accurately.
- •Willingness to participate in behavioral treatments for alcoholism.
- •Provide evidence of stable residence in the last month prior to enrollment in the study and have no plans to move during the next three months.
排除标准
- •Please contact site for additional information
研究组 & 干预措施
Ondansetron
Ondansetron + cognitive behavioral therapy
干预措施: ondansetron + cognitive behavioral therapy (Drug)
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)
Ondansetron + Topiramate
Ondansetron + Topiramate + cognitive behavioral therapy
干预措施: ondansetron + topiramate + cognitive behavioral therapy (Drug)
结局指标
主要结局
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
时间窗: Throughout the study
Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT
次要结局
- Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors(Throughout the study)
研究者
Bankole Johnson
Chair of Psychiatry and Neurobehavioral Sciences
University of Virginia