Clinical trial NCT02351167: Genetically Informed Smoking Cessation Trial
Official title: Genetically Informed Smoking Cessation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: Smoking cessation
Counseling
Genetics and Genomics
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2015-01-30
Enrollment: 822
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: 7-day Point Prevalence Quit Rate
timeFrame: Week 12
Secondary outcomes:
measure: Continuous Abstinence
timeFrame: 12 weeks (with first 1 week initial grace period)
measure: 7-day Point Prevalence Quit Rate
timeFrame: Week 24
measure: Number of Days to Lapse
timeFrame: Assessed from the target quit day through 52 weeks
measure: Number of Days to Relapse
timeFrame: Assessed from the target quit day through 52 weeks
measure: Initial Cessation
timeFrame: Assessed for the first seven days after the target quit date
measure: Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
timeFrame: 0-52 Weeks
measure: Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
timeFrame: 0-52 Weeks
measure: Medication Adherence
timeFrame: Pre-quit week to Week 12
measure: Side Effects
timeFrame: Pre-quit week to Week 12
measure: Withdrawal
timeFrame: Pre-quit, quit, week 1, week 2, and week 4
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Li-Shiun Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen LS, Baker TB, Miller JP, Bray M, Smock N, Chen J, Stoneking F, Culverhouse RC, Saccone NL, Amos CI, Carney RM, Jorenby DE, Bierut LJ. Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled Trial. Clin Pharmacol Ther. 2020 Dec;108(6):1315-1325. doi: 10.1002/cpt.1971. Epub 2020 Aug 4.