Effects of Smoking Environments on Brain Reactivity
Condition: Cigarette Smoking
Intervention: Nicotine patch
Intervention description: 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.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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)