Status:
COMPLETED
Effects of Smoking Environments on Brain Reactivity
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Conditions:
Cigarette Smoking
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 spec...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- marijuana will be tested for but will not be exclusionary;
- 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
- currently pregnant, breast feeding or likely to become pregnant;
- a quit attempt resulting in greater than 3 days of abstinence in the past 30 days
- presence of conditions that would make MRI unsafe (e.g., pacemaker)
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2019
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03421210
Start Date
March 5 2018
End Date
December 23 2019
Last Update
January 19 2021
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705