Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks
研究概览
简要总结
The investigators' hypothesis is that add-on varenicline will be effective (versus placebo) in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who are motivated to quit smoking within four weeks. This primary outcome will be assessed from randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the investigators also hypothesize that varenicline will prevent relapse in the subsequent 12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as well as its safety for use in stable bipolar patients when used as an add-on treatment for smoking cessation.
The investigators plan to test these hypotheses by conducting a randomized, placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up with them three months later to evaluate extended abstinence.
详细描述
OBJECTIVE:
Our primary objective is to determine if adjunctive varenicline will be efficacious (vs. placebo) in initiating abstinence from smoking cigarettes in subjects with stable bipolar disorder who are motivated to quit smoking during a 12-week treatment phase. A secondary outcome is to determine whether those who initiated abstinence during the 12-week treatment phase will maintain abstinence in the subsequent three-month follow-up period off study medications.
Additional outcomes: we plan to test the effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as well as its safety for use in stable bipolar patients when used as an adjunctive treatment for smoking cessation.
RESEARCH PLAN:
We plan to test these hypotheses by conducting a randomized, placebo-controlled, treatment trial of Chantix. Measures of CO levels in expired air (10 ppm or lower), self-reported abstinence, and psychopathology ratings will be used to evaluate primary and secondary outcomes along with safety assessments. Smoking abstinence is defined as 7-day point prevalence of self-reported no smoking verified objectively by expired CO levels of 10 ppm or less, and will be assessed at 12-weeks (or end of treatment phase) as the primary outcome. The same criterion will be used to assess maintenance of abstinence in the non-treatment phase, i.e. at 24 weeks or end of study.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Varenicline
We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
干预措施: Varenicline (Drug)
Placebo
We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
干预措施: Placebo (Drug)
结局指标
主要结局
7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks
时间窗: 24 weeks
To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence
7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks
时间窗: 12 weeks
To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks
次要结局
- Participants Experiencing Neuropsychiatric Events(24 weeks)
研究者
K.N. Roy Chengappa
Professor of Psychiatry
University of Pittsburgh