Genetically Informed Smoking Cessation Trial

• Status: Completed
• Trial end date: 2019-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Treatments: Nicotine; Varenicline

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.