Genetically Informed Smoking Cessation Trial (GISC)

The Washington University

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: Combination NRT (Nicotine patch, Nicotine lozenge); Drug: Placebo; Behavioral: Intensive smoking counseling; Drug: Varenicline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02351167

201305128

1R01DA038076-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 822 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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822 participants in 3 patient groups, including a placebo group

Combination NRT and Counseling

Active Comparator group

Description:

Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.

Treatment:

Behavioral: Intensive smoking counseling

Drug: Combination NRT (Nicotine patch, Nicotine lozenge)

Varenicline (Chantix) and Counseling

Active Comparator group

Description:

Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.

Treatment:

Drug: Varenicline

Behavioral: Intensive smoking counseling

Placebo Medicine and Counseling

Placebo Comparator group

Description:

Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.

Treatment:

Behavioral: Intensive smoking counseling

Drug: Placebo