Genetically Informed Smoking Cessation Trial
GISC
2 other identifiers
interventional
822
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2015
CompletedFirst Posted
Study publicly available on registry
January 30, 2015
CompletedStudy Start
First participant enrolled
May 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedResults Posted
Study results publicly available
March 16, 2020
CompletedSeptember 22, 2020
September 1, 2020
3.6 years
January 26, 2015
December 20, 2019
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
7-day Point Prevalence Quit Rate
The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.
Week 12
Secondary Outcomes (10)
Continuous Abstinence
12 weeks (with first 1 week initial grace period)
7-day Point Prevalence Quit Rate
Week 24
Number of Days to Lapse
Assessed from the target quit day through 52 weeks
Number of Days to Relapse
Assessed from the target quit day through 52 weeks
Initial Cessation
Assessed for the first seven days after the target quit date
- +5 more secondary outcomes
Study Arms (3)
Combination NRT and Counseling
ACTIVE COMPARATORCombination 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.
Varenicline (Chantix) and Counseling
ACTIVE COMPARATORVarenicline (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.
Placebo Medicine and Counseling
PLACEBO COMPARATORPlacebo 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.
Interventions
Eligibility Criteria
You may qualify if:
- Adult (≥21 years of age), seeking treatment for smoking cessation.
- Able to speak English,
- Active smoking (Cigarettes Per Day (CPD) ≥5), and exhaled Carbon Monoxide (CO) ≥8 ppm
- Agree to participate in this randomized smoking cessation trial with follow up assessments up to 12 months.
You may not qualify if:
- Pregnancy or breast feeding,
- 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,
- Allergy to nicotine patch, lozenge, or varenicline,
- Unwillingness to prevent pregnancy during the medication phase and 1 month afterwards (women only),
- Significant cardiac conditions (myocardial infarction, unstable angina, coronary angioplasty, cardiac bypass) or serious arrhythmia in past 6 months,
- Current heavy alcohol consumption (≥6 drinks/day, 6 days/week),
- Active psychosis or poorly controlled depression within the past 6 months,
- Any prior suicide attempt or suicidal ideation within the past 6 months,
- End stage renal disease with hemodialysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
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.
PMID: 32602170DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Li-Shiun Chen, M.D.
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Li-Shiun Chen, M.D.
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2015
First Posted
January 30, 2015
Study Start
May 20, 2015
Primary Completion
December 26, 2018
Study Completion
August 31, 2019
Last Updated
September 22, 2020
Results First Posted
March 16, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share