Effects of Smoking Environments on Brain Reactivity

Phase 4

Completed

• Conditions: Cigarette Smoking
• Interventions: Drug: Nicotine patch

• Registration Number: NCT03421210
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Study Start: 2018-03-05
• Primary Completion: 2019-10-16
• Study Completion: 2019-12-23
• Results First Submitted: 2020-10-15
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-01
• Results First Posted: 2020-12-22
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. generally healthy [(i.e. ambulatory, not currently sick)]
2. between the ages of 18 and 65
3. smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year
4. an expired carbon monoxide (CO) concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine >1000 ng/mL (NicAlert = 6).
5. interest in quitting smoking within the timeframe of the experiment.
6. ability to identify 4 personal smoking and 4 personal non-smoking places.
7. right handed as measured by a three-item scale used in our laboratory
8. own a smartphone

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Exclusion Criteria

1. immediate or no desire to quit smoking;

2. inability to attend all required experimental sessions;

3. use of other tobacco products or e-cigarettes more than 9 days in the past 30 days;

4. current alcohol or drug abuse;

5. positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and Phencyclidine(PCP)

   1. marijuana will be tested for but will not be exclusionary;
   2. participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded;
   3. participants failing the toxicology screen will be allowed to re-screen once;

6. current use of nicotine replacement therapy or other smoking cessation treatment;

7. screening systolic BP greater than 140 (participants failing for blood pressure will be allowed to rescreen once)

8. screening diastolic BP greater than 90 (participants failing for blood pressure will be allowed to rescreen once)

9. screening heart rate greater than 100 (participants failing for heart rate will be allowed to rescreen once)

10. presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies)

11. report of significant health problems including but not restricted to (e.g. chronic hypertension, emphysema, seizure disorder, history of significant heart problems, heart disease, heart attack in the past 90 days, irregular heartbeat)

12. medical condition that may contraindicate participation in the opinion of the investigator and study physician.

13. current major psychiatric disease such as schizophrenia or schizoaffective disorder

14. currently pregnant, breast feeding or likely to become pregnant;

15. a quit attempt resulting in greater than 3 days of abstinence in the past 30 days

16. presence of conditions that would make MRI unsafe (e.g., pacemaker)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nicotine Replacement Therapy	Nicotine patch	Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.

Primary Outcome Measures

Name	Time	Method
Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures	4 weeks	Using fMRI the investigators examined brain function during cue-reactivity. During the scan, participants viewed pictures of personal and non-personal environments.; Contrast of parameter estimate (COPE) values for the difference between personal smoking environment pictures and non-personal smoking environment pictures were extracted from anatomically defined brain regions using FSL's featquery for analysis.

Secondary Outcome Measures

Name	Time	Method
Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire	2 weeks after quitting smoking	EMA will be used to evaluate craving daily for 2 weeks after quitting. Subjects will rate their craving on a single item (How strong is your current urge to smoke?) using a scale from 1 "very slightly or not at all" to 5 "extremely".
Number of Participants Experiencing Relapse	Weeks 1, 3, 6, and 10 weeks after quitting.	Relapse defined as 7 consecutive days smoking at least 1 cigarette per day. Individuals lost to contact are presumed to have relapsed following their last visit.

Trial Locations

Locations (1)

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