Effects of Smoking Environments on Craving and Smoking (CameraCue2.0)

Not Applicable

Completed

• Conditions: Cigarette Smoking
• Interventions: Drug: Nicotine Patch; Drug: Varenicline; Drug: Placebo Nicotine Patch; Drug: Placebo Capsule

• Registration Number: NCT02551692
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Study Start: 2016-01
• Primary Completion: 2019-01-07
• Study Completion: 2019-01-07
• Status Verified: 2020-01
• Results First Submitted: 2020-01-06
• Results First Submitted QC: 2020-01-06
• Last Update Submitted: 2020-01-06
• Results First Posted: 2020-01-18
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NRT	Nicotine Patch	-
PLAC	Nicotine Patch	-
PLAC	Placebo Nicotine Patch	-
PLAC	Placebo Capsule	-
NRT	Placebo Capsule	-
VAR	Placebo Nicotine Patch	-
VAR	Varenicline	-

Primary Outcome Measures

Name	Time	Method
Change in Craving Score During Cue Exposure Task	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	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	Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)	Measured by number of puffs.

Trial Locations

Locations (1)

Duke Medical Center; 🇺🇸 Durham, North Carolina, United States