Saint Louis, Missouri 63110


Purpose:

The investigators' goal is to identify the most appropriate smoking cessation treatments for smokers based on genetic information. Smokers try to quit smoking but relapses are common.


Study summary:

The investigators' goal is to determine whether genetic markers can be used to optimize smoking cessation pharmacotherapy to enhance efficacy, medication adherence, and reduce side effects. Smoking is a leading cause of preventable death and disability, and smoking cessation reverses the risk of mortality. However, cessation failure is common despite available cessation medications, which are associated with different efficacy, side effects, adherence, use constraints, and costs. This challenge can be addressed by improving current treatments via personalized medicine based on individual genetic markers to maximize efficacy and minimize side effects. The investigators propose a prospective, genotype-based stratified randomization trial to compare two smoking cessation medications (combination NRT [patch and lozenge], varenicline vs. placebo) for 3 months in 720 smokers with known genotypes.


Criteria:

Inclusion Criteria: 1. Adult (≥21 years of age), seeking treatment for smoking cessation. 2. Able to speak English, 3. Active smoking (Cigarettes Per Day (CPD) ≥5), and exhaled Carbon Monoxide (CO) ≥8 ppm 4. Agree to participate in this randomized smoking cessation trial with follow up assessments up to 12 months. Exclusion Criteria: 1. Pregnancy or breast feeding, 2. Active use or recent use (< or equal to 1 month) of medication or e-cigarettes for nicotine dependence/smoking cessation, or use of e-cigarettes for more than 9 days in the prior month, 3. Allergy to nicotine patch, lozenge, or varenicline, 4. Unwillingness to prevent pregnancy during the medication phase and 1 month afterwards (women only), 5. Significant cardiac conditions (myocardial infarction, unstable angina, coronary angioplasty, cardiac bypass) or serious arrhythmia in past 6 months, 6. Current heavy alcohol consumption (≥6 drinks/day, 6 days/week), 7. Active psychosis or poorly controlled depression within the past 6 months, 8. Any prior suicide attempt or suicidal ideation within the past 6 months, 9. End stage renal disease with hemodialysis.


NCT ID:

NCT02351167


Primary Contact:

Principal Investigator
Li-Shiun Chen, M.D.
Washington University Asst Prof of Psychiatry

Li-Shiun L Chen, M.D.
Phone: 314-362-3932
Email: li-shiun@wustl.edu


Backup Contact:

Email: smockn@wustl.edu
Nina L Smock, B.A.
Phone: 314-362-1854


Location Contact:

Saint Louis, Missouri 63110
United States

Li-Shiun Chen, M.D.
Phone: 314-362-3932
Email: li-shiun@wustl.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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