A Randomized Phase 2 Trial of Varenicline for Helping Adults Quit E-Cigarettes Assessing Effects on Cancer-Related Health Markers

What this Trial Is About

Researchers are evaluating the effectiveness of varenicline, compared to a placebo, for helping adults who regularly use e-cigarettes to quit. This phase 2 randomized, placebo-controlled trial focuses on treatment-seeking adults who report daily e-cigarette use, aiming to understand if varenicline can increase quit rates and how quitting affects health-related biomarkers. Participants will be randomly assigned to one of two groups one group will receive varenicline titrated to 2 mg daily over 12 weeks along with brief counseling and self-management resources, while the other group will receive a matching placebo with the same counseling and resources. Assessments will occur every 3 weeks during the treatment period, with a final follow-up at week 26. Throughout the study, participants will complete evaluations every three weeks and a final visit at 26 weeks to measure abstinence from e-cigarette use and assess changes in health biomarkers related to cessation. The primary outcome is the number of participants abstinent at week 12, with additional outcomes measured at week 26. The study includes monitoring for safety and treatment adherence over the 26-week period.

A Trial of Varenicline for E-cigarette Cessation