Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults
Summary
This is randomized, placebo-controlled clinical trial in treatment-seeking adults who report regular e-cigarette use to test the hypothesis that varenicline is efficacious for quitting e-cigarettes.
Detailed description
Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) or matching placebo plus brief cessation advice from a counselor and self-management resources. All participants will also complete research assessments every 3 weeks during treatment and a final follow-up visit at week 26. The primary objective is to test the efficacy of varenicline vs. placebo on e-cigarette quit rates. We will also evaluate predictors and moderators of outcomes and explore changes in health biomarkers following e-cigarette cessation treatment.
Arms & interventions
- DrugVarenicline 1mg BID
12 weeks following the standard titration of 1 mg, twice daily
- DrugPlacebo
Matching placebo twice daily
Outcome measures
Primary
Number of Participants Abstinent From E-cigarette Use at Week 12
7-day point-prevalence e-cigarette abstinence (PPA) at Week 12 defined as no ecigarette use \[and no use of any combusted tobacco product\], not even a puff, biochemically verified by saliva cotinine
Time frame: Week 12
Secondary
Number of Participants Abstinent From E-cigarette Use at Week 26
Time frame: Week 26
Eligibility criteria
Study locations (2)
Yale Cancer Center/Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06520
Hollings Cancer Center at MUSC (HCC)
Charleston, South Carolina, 29425