A Double-Blind, Randomized, Controlled Phase III Trial Investigating Efficacy and Safety of Varenicline for Vaping Cessation in Adult Users

ABSTRACT Background Vaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and outcomes for e-cigarettes users who want to quit. Methods Eligible patients were randomized to either varenicline (1 mg, administered twice daily for 12 weeks) or placebo treatment (administered twice daily, for 12 weeks) combined with vaping cessation counseling. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up, nontreatment phase. The primary efficacy endpoint of the study was biochemically validated continuous abstinence rate (CAR) at weeks 4 to 12. Secondary efficacy end points were the CAR at weeks 4 to 24 and 7-day point prevalence of vaping abstinence at weeks 12 and 24. Results CAR was significantly higher for varenicline vs placebo at each interval: weeks 4-12, 40.0% and 20.0%, respectively (OR = 2.67, 95% CI = [1.25 - 5.68], P = 0.011); weeks 4-24, 34.3% for varenicline and 17.2% for placebo (OR = 2.52, 95% CI = [1.14 - 5.58], P = 0.0224). The 7-day point prevalence of vaping abstinence was also higher for the varenicline than placebo at each time point. Serious adverse events were infrequent in both groups and not treatment-related. Conclusions Inclusion of varenicline and counseling in a vaping cessation program for EC users intending to quit may result in prolonged abstinence. These positive findings may also help guiding future recommendations for vaping cessation by health authorities and healthcare providers.