Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- 4-week Continuous Abstinence From Smoking
研究概览
简要总结
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.
详细描述
This study is a 12-week, double-blind, placebo-controlled trial to test the efficacy of topiramate versus placebo as an aid to smoking cessation for recovering alcohol dependent men. Another aim of the study is to explore whether or not topiramate reduces relapse to alcohol use in patients with comorbid alcohol and nicotine dependence. All participants will receive a standardized psychosocial intervention in combination with the medication (or placebo). Following completion of the treatment phase of the study, participants will enter a 24-week follow-up period during which the longer-term outcome of the intervention will be assessed.
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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects will be included if they:
- •are 18-70 years of age, inclusive;
- •are male outpatients with a diagnosis of DSM-IV-TR nicotine dependence and alcohol dependence in early full remission (1-36 months abstinence);
- •are current tobacco smokers who smoke an average of 10 or more cigarettes per day in the two months prior to the screening visit;
- •are motivated to try to quit smoking and maintain abstinence from alcohol and other illicit drugs;
排除标准
- •Subjects will be excluded if they:
- •have any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, or thyroid disease;
- •have a current significant neurologic, hepatic, renal, gastrointestinal, pulmonary, metabolic, cardiovascular, infectious, or endocrine disease;
- •have a history of known hypersensitivity to topiramate;
- •in the investigator's judgment, pose a current suicidal or homicidal risk;
- •have taken any investigational drug within 30 days of baseline; and
- •have a current seizure disorder or a history of severe alcohol withdrawal (alcohol withdrawal seizures, hallucinations / illusions, delirium tremens).
研究组 & 干预措施
Topiramate
The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.
干预措施: Topiramate (Drug)
Placebo
90 participants, will receive matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
4-week Continuous Abstinence From Smoking
时间窗: Weeks 8-12 of treatment.
This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.
次要结局
- Percent Relapsing to Any Drinking or Illicit Drug Use(12-week treatment phase, 36-week combined treatment and follow-up)