In a randomized clinical trial of 261 adolescents and young adults, varenicline was found to increase vaping quit rates when combined with weekly behavioral counseling.
At 12 weeks, 51% of the participants receiving varenicline achieved continuous vaping abstinence, confirmed by self-report and biochemical testing, compared with 14% in the placebo group and 6% in the minimal-support group. The adjusted odds ratio for abstinence with varenicline vs placebo was 6.5 (95% confidence interval = 3.0–14.1, P < .001).
By week 24, 28% of the participants in the varenicline group remained abstinent compared with 7% in the placebo group and 4% in the enhanced usual care group. Abstinence was verified using cotinine testing via saliva samples.
The trial, conducted from June 2022 to May 2024, enrolled youth aged 16 to 25 years who vaped nicotine at least 5 days per week and were motivated to quit. All participants were referred to a text-based cessation program. Those in the varenicline and placebo groups received 12 weeks of either active drug or placebo and weekly 20-minute remote behavioral counseling.
Participants taking varenicline reported lower nicotine withdrawal symptoms, cravings, and mood-related distress over time. Compared with placebo, mean scores were significantly lower on validated scales for withdrawal, craving, and anxiety-related symptoms.
Varenicline was generally well tolerated. Treatment-emergent adverse events occurred in 86% of varenicline users comparable to 79% in the other groups. The most common effects were nausea (58%), vivid dreams (39%), and insomnia (31%). Two participants in the varenicline group and one in the placebo group discontinued treatment because of adverse events. No drug-related serious events occurred. None of the participants who quit vaping initiated regular tobacco smoking.
Study adherence was high. Ninety-seven percent completed the trial. In the varenicline group, over 80% of counseling sessions were attended, and medication adherence, confirmed by pill counts and video submissions, exceeded 70%.
At baseline, the participants reported frequent e-cigarette use and high nicotine dependence. More than 60% had a psychiatric diagnosis, and 72% reported cannabis use in the past month. Despite these comorbidities, adherence and engagement remained high.
The researchers stated this was among the first randomized trials to evaluate a pharmacologic agent for nicotine vaping cessation in youth. Prior studies have focused on adult populations, despite increasing e-cigarette use among adolescents and young adults.
The trial was conducted at a single U.S. site and funded by the National Institutes of Health. Full disclosures are available in the study.
Source: JAMA Network