Effects of Smoking Environments on Craving and Smoking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change in Craving Score During Cue Exposure Task
研究概览
简要总结
The goal of this study is to evaluate the effects of varenicline versus nicotine replacement versus placebo on personal smoking environment cue (PSE) reactivity. The results of this study will inform whether first-line pharmacotherapies for nicotine dependence (e.g. nicotine patch, varenicline) alter reactivity to environment cues. The investigators propose to identify 120 regular cigarette smokers who will complete 10 visits (1 screening visit, 1 training visit, 1 camera turn-in 2 cue exposure sessions and 4 post-quit medication check sessions). Smokers will be randomized to one of three medication conditions: placebo (PLAC; n=40), transdermal nicotine patch (NRT; n=40) or varenicline (VAR; n=40) in a double blind, double-dummy design. Reactivity variables (craving, latency to smoke, and smoke intake) will be entered into 3 (Medication: NRT, VAR, PLAC) x 2 (Environment: smoking, nonsmoking) repeated measures ANOVAs with random-effects. The investigators hypothesize that personal smoking, as compared to nonsmoking environments, will be associated with greater reactivity (i.e. increased craving and smoke intake; decreased latency to smoke). A Medication x Environment interaction will be characterized by decreased reactivity to smoking as compared to nonsmoking environments in the VAR and NRT groups as compared to the PLAC group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NRT
干预措施: Nicotine Patch (Drug)
NRT
干预措施: Placebo Capsule (Drug)
VAR
干预措施: Varenicline (Drug)
VAR
干预措施: Placebo Nicotine Patch (Drug)
PLAC
干预措施: Nicotine Patch (Drug)
PLAC
干预措施: Placebo Nicotine Patch (Drug)
PLAC
干预措施: Placebo Capsule (Drug)
结局指标
主要结局
Change in Craving Score During Cue Exposure Task
时间窗: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
Scores range from 0 (no craving) to 100 (extreme craving).
Change in Latency to Smoke During Cue Exposure Task
时间窗: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
The latency is the interval between smoking one cigarette and wanting, craving, or needing another.
Change in Smoke Intake During Cue Exposure Task
时间窗: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
Measured by number of puffs.
次要结局
未报告次要终点
