A Trial of Varenicline for E-cigarette Cessation

Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults

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.

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.

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