Clinical trial NCT03421210: Effects of Smoking Environments on Brain Reactivity
Official title: Effects of Smoking Environments on Brain Reactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cigarette Smoking
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2018-02-05
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

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)

Primary outcomes:
measure: Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures
timeFrame: 4 weeks
Secondary outcomes:
measure: Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire
timeFrame: 2 weeks after quitting smoking
measure: Number of Participants Experiencing Relapse
timeFrame: Weeks 1, 3, 6, and 10 weeks after quitting.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Francis J McClernon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: