Expired Study
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Durham, North Carolina 27705


Purpose:

The central objective of the project is to evaluate the effect of incorporating smoking related contexts into very low nicotine content (VLNC) cigarette extinction trials on clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking (N=80) will be interviewed and trained to take pictures where they smoke cigarettes. Following taking these pictures, participants will then be switched to smoke VLNCs while wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period, half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of multiple context extinction (MCE+) during which they will view smoking-related environments and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of the three weeks, participants will quit smoking and continue to wear the nicotine patch while being followed during a 10-week abstinence period. Participants will also complete a follow-up phone call 6 months after their quit day.


Criteria:

Inclusion Criteria: - generally healthy (i.e. ambulatory, not currently sick) - interest in quitting smoking - smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year - an expired carbon monoxide concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine > 1000 ng/mL to confirm daily smoking (NicAlert=6) Exclusion Criteria: - inability to attend all required experimental sessions - desire to quit smoking prior to the study quit date - a quit attempt resulting in greater than 3 days of abstinence in the past 30 days - report of significant health problems including but not restricted to (e.g. chronic hypertension, emphysema, seizure disorder, history of significant heart problems) - unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the study physician) - schizophrenia and schizoaffective disorder - psychiatric medication changes (e.g. new prescriptions, changes in dosages, or discontinuation of medications) in the past 3 months that was a result of negative changes in symptoms - use of other tobacco products or e-cigarettes more than 9 days in the past 30 days - current alcohol or drug abuse - use of illegal drugs (excluding marijuana) or drugs without a valid prescription as measured by urine drug screen - current use of nicotine replacement therapy or other smoking cessation treatment - use of Theophylline for asthma - presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies) - previous participation in a study within the past year involving use of Spectrum cigarettes - systolic BP greater than or equal to 140 (participants failing for blood pressure will be allowed to rescreen once) - diastolic BP greater than or equal to 90 (participants failing for blood pressure will be allowed to rescreen once) - heart rate greater than or equal to 100 (participants failing for heart rate will be allowed to rescreen once) - blood alcohol level >0.0 (participants failing the blood alcohol screen will be allowed to rescreen once) - pregnant, trying to become pregnant, or breastfeeding


NCT ID:

NCT02538042


Primary Contact:

Principal Investigator
Francis J McClernon, Ph.D
Duke University


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27705
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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