Varenicline, combined with behavioral counseling, is well tolerated and increases vaping cessation compared with placebo in youth who vape nicotine, do not regularly smoke tobacco and want to reduce or quit vaping, according to a randomized trial published April 23 in JAMA.

In this single center study, A. Eden Evins, MD, et al., randomized 261 youths (16 to 25 years old) who vaped nicotine five or more days a week to varenicline plus behavioral counseling, placebo plus behavioral counseling or enhanced usual care. Varenicline was titrated to 1 mg twice daily over seven days and administered for 12 weeks. Behavioral counseling included 12 weekly 20-minute Zoom sessions. Nearly all (97%) completed the trial.

Results showed that 51% of individuals in the varencline group compared with 14% in the placebo group abstained from vaping during weeks nine to 12 and that 28% and 7% abstained for weeks nine to 24 (adjusted odds ratio [aOR], 6.5 and 6.0, respectively, p<0.001 for both.

Moreover, continuous abstinence rates were higher with varenicline compared with enhanced usual care for the same two time periods: 51% vs. 6% and 28% vs. 4% (aOR, 16.9 and 11.0, respectively). Comparing placebo and the enhanced usual care groups, no significant differences were observed for abstinence rates.

Generally, varenicline was well tolerated. Treatment-emergent adverse events were reported by 86%, 79% and 79% of the varenicline, placebo and enhanced usual care groups, while there were no drug-related serious adverse events overall.

The authors write the "higher rates of continuous abstinence at 24 weeks in the varenicline vs. the placebo groups, support the finding of a benefit of varenicline over behavioral vaping cessation interventions alone in this population."

The authors highlight the importance of having an effective and well tolerated vaping cessation pharmacotherapy for this population. They add, "converging evidence indicates that earlier age of drug initiation is associated with more rapid transition to substance use disorder and that adolescent nicotine exposure specifically increases subsequent tobacco smoking and other substance use disorders."