Genetically Informed Smoking Cessation Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

822 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-20

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Combination NRT and Counseling

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.

Group Type ACTIVE_COMPARATOR

Combination NRT (Nicotine patch, Nicotine lozenge)

Intervention Type DRUG

Intensive smoking counseling

Intervention Type BEHAVIORAL

Varenicline (Chantix) and Counseling

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.

Group Type ACTIVE_COMPARATOR

Varenicline

Intervention Type DRUG

Intensive smoking counseling

Intervention Type BEHAVIORAL

Placebo Medicine and Counseling

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intensive smoking counseling

Intervention Type BEHAVIORAL

Interventions

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Combination NRT (Nicotine patch, Nicotine lozenge)

Intervention Type DRUG

Varenicline

Intervention Type DRUG

Placebo

Intervention Type DRUG

Intensive smoking counseling

Intervention Type BEHAVIORAL

Other Intervention Names

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Nicoderm CQ Nicotine Polacrilex Lozenge Chantix

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes