Skip to main content
Clinical Trials/NCT02551692
NCT02551692
Completed
Not Applicable

Effects of Smoking Environments on Craving and Smoking

Duke University1 site in 1 country125 target enrollmentJanuary 2016

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
January 7, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Study Sites (1)

Loading locations...

Similar Trials