Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Cigarette Reduction
研究概览
简要总结
The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must smoke at least 10 cigarettes per day for past 6-months
- •Must have a working cellular or land-line phone
排除标准
- •Must not be thinking of quitting in the next 30 days, but be interested in cutting down- Must not regularly (more than 1x/month) use tobacco products other than cigarettes
- •Must not be currently receiving tobacco dependence treatment counseling
- •Must not currently be taking varenicline, bupropion, nortriptyline, or any nicotine preparations (gum, lozenge, patch, spray, inhaler)
- •Must not have positive screen on SCID-I/NP Psychotic Screen
- •Must have no contraindications to using varenicline, including pregnancy, as measured by Medical History Form
研究组 & 干预措施
varenicline
干预措施: Varenicline (Drug)
placebo pill
干预措施: Placebo pill (Drug)
结局指标
主要结局
Cigarette Reduction
时间窗: At 6-month follow-up
50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.
次要结局
未报告次要终点
研究者
Marc L. Steinberg, Ph.D.
Associate Professor
Rutgers University