St. Louis, Missouri 63110


Purpose:

Our 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:

Our 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. We 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. This study uses a stratified randomization trial design based on a subject's pertinent genotype for smoking cessation. Specifically, in Aim 1, we will determine if CHRNA5 genotype moderates the effect of medication (combination NRT, varenicline, vs. placebo) on abstinence. In Aim 2, we will determine if CHRNA5 genotype predicts medication adherence and side effects. In Aim 3, we will incorporate multiple genotypes and other predictors in order to develop a clinical treatment assignment algorithm for cessation success. This work can result in improved physician care of patients who smoke, overall smoking cessation success, and prevention of cancer, heart, and lung disease.


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

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


Backup Contact:

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


Location Contact:

St. Louis, Missouri 63110
United States

Nina Smock
Phone: 314-747-7849
Email: behaviorandgenetics@psychiatry.wustl.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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