Effects of Smoking Environments on Brain Reactivity

NCT03421210 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: Pro000891831R01DA038442
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures

  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.

  4 weeks

Secondary Outcomes (2)

• Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire

  2 weeks after quitting smoking

• Number of Participants Experiencing Relapse

  Weeks 1, 3, 6, and 10 weeks after quitting.

Study Arms (1)

Nicotine Replacement Therapy

OTHER

Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.

Drug: Nicotine patch

Interventions

Nicotine patch DRUG

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.

Nicotine Replacement Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• immediate or no desire to quit smoking;
• inability to attend all required experimental sessions;
• use of other tobacco products or e-cigarettes more than 9 days in the past 30 days;
• current alcohol or drug abuse;
• positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and Phencyclidine(PCP)
• participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded;
• participants failing the toxicology screen will be allowed to re-screen once;
• current use of nicotine replacement therapy or other smoking cessation treatment;
• screening systolic BP greater than 140 (participants failing for blood pressure will be allowed to rescreen once)
• screening diastolic BP greater than 90 (participants failing for blood pressure will be allowed to rescreen once)
• screening heart rate greater than 100 (participants failing for heart rate will be allowed to rescreen once)
• presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies)
• 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)
• medical condition that may contraindicate participation in the opinion of the investigator and study physician.
• current major psychiatric disease such as schizophrenia or schizoaffective disorder

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Anthony DeVito, MD
• Organization: Duke University

anthony.devito@duke.edu

919-684-1377

Study Officials

• Francis J McClernon, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 5, 2018
• Study Start: March 5, 2018
• Primary Completion: October 16, 2019
• Study Completion: December 23, 2019
• Last Updated: January 19, 2021
• Results First Posted: December 22, 2020

Record last verified: 2020-12

Locations

US (1)