Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults
Yale University
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * report daily use of an e-cigarette containing nicotine * live in Connecticut or South Carolina Exclusion Criteria: * regular use of other tobacco products besides e-cigarettes * medical contraindications for varenicline use * current treatment for tobacco cessation * lack proficiency in English
Interventions
- DrugVarenicline 1mg BID
12 weeks following the standard titration of 1 mg, twice daily
- DrugPlacebo
Matching placebo twice daily
Locations (2)
- Yale Cancer Center/Smilow Cancer Hospital at Yale-New HavenNew Haven, Connecticut
- Hollings Cancer Center at MUSC (HCC)Charleston, South Carolina