NCT03421210

Effects of Smoking Environments on Brain Reactivity

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to evaluate correlations between brain reactivity (as assessed via functional magnetic resonance imaging (fMRI) following 24-h abstinence) and the amount of smoking in a specific location. The investigators will use ecological momentary assessment (EMA) to ask smokers to rate their exposure to, and smoking in, specific personal smoking environment cues (PSEs) over the course of 2 weeks before quitting smoking and 2 weeks after quitting smoking. The investigators propose to identify 48 regular cigarette smokers who will complete 8 visits (1 screening visit, 1 training visit, 1 camera turn-in visit, 1 fMRI session and 4 post-quit medication check sessions). Multiple methods will be used to test hypotheses about brain functioning during cue-reactivity (CR). The investigators will examine correlation between brain responses to smoking environments (minus non-smoking environments) and smoking cessation outcomes (i.e. days to lapse, days to relapse). Our EMA+Global Positioning System (GPS) analysis will primarily focus on locations where smokers smoke before and after quitting smoking. The investigators will evaluate whether EMA-assessed smoking intensity values are correlated with brain responses to these personal smoking environments.

Conditions

• Cigarette Smoking

Interventions

Type	Name	Description
DRUG	Nicotine patch	Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.

Timeline

• Start date: 2018-03-05
• Primary completion: 2019-10-16
• Completion: 2019-12-23
• First posted: 2018-02-05
• Last updated: 2021-01-19
• Results posted: 2020-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study