Effects of Smoking Environments on Craving and Smoking
Overview
- Phase
- Not Applicable
- Intervention
- Nicotine Patch
- Conditions
- Cigarette Smoking
- Sponsor
- Duke University
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Change in Craving Score During Cue Exposure Task
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
NRT
Intervention: Nicotine Patch
NRT
Intervention: Placebo Capsule
VAR
Intervention: Varenicline
VAR
Intervention: Placebo Nicotine Patch
PLAC
Intervention: Nicotine Patch
PLAC
Intervention: Placebo Nicotine Patch
PLAC
Intervention: Placebo Capsule
Outcomes
Primary Outcomes
Change in Craving Score During Cue Exposure Task
Time Frame: 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
Time Frame: 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
Time Frame: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
Measured by number of puffs.