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临床试验/NCT02551692
NCT02551692已完成不适用

Effects of Smoking Environments on Craving and Smoking

Duke University1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

NRT

Placebo Comparator

干预措施: Nicotine Patch (Drug)

NRT

Placebo Comparator

干预措施: Placebo Capsule (Drug)

VAR

Placebo Comparator

干预措施: Varenicline (Drug)

VAR

Placebo Comparator

干预措施: Placebo Nicotine Patch (Drug)

PLAC

Placebo Comparator

干预措施: Nicotine Patch (Drug)

PLAC

Placebo Comparator

干预措施: Placebo Nicotine Patch (Drug)

PLAC

Placebo Comparator

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

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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