Results from a randomized trial suggest varenicline combined with behavioral counseling significantly improves vaping cessation rates among young people who do not regularly smoke tobacco.1
“Before this study, there was really no known treatment for vaping cessation in young people, most of whom had never smoked cigarettes,” said study author A. Eden Evins, MD, Founding Director of the Center for Addiction Medicine at Massachusetts General Hospital, Boston. “Pediatricians or school health services would be highly unlikely to prescribe medication for what is often considered a fairly minor problem.”
Instead, she said they would more likely recommend behavioral interventions, such as the Truth Initiative text-based quit-vaping program called This is Quitting (TIQ), which has since been incorporated into the EX Program, or the National Cancer Institute texting program, SmokefreeTXT for Teens.
In the study published in the Journal of the American Medical Association, Dr. Evins and colleagues recruited young individuals (ages 16-25) in Massachusetts who self-reported nicotine vaping five or more days per week in the past 90 days. This three-arm randomized trial (N = 261) compared varenicline (titrated to 1 mg twice daily for 12 weeks) plus behavioral counseling and referral to the TIQ program, identical placebo plus behavioral counseling and TIQ referral, and enhanced usual care (referral to TIQ program only). The primary outcome was continuous nicotine vaping abstinence, biochemically verified by saliva cotinine levels during study weeks 9 through 12.1
The mean age of study participants was 21 years, and more than half were female and White. The researchers found that continuous abstinence rates during weeks 9 through 12 were 51% for varenicline vs 14% for placebo (adjusted OR [aOR], 6.5 [95% CI, 3.0-14.1]; P < .001), while continuous abstinence rates from weeks 9 through 24 were 28% for varenicline vs 7% for placebo (aOR, 6.0 [95% CI, 2.1-16.9]; P < .001). Varenicline also outperformed TIQ referral only, with abstinence rates of 51% vs 6% (aOR, 16.9 [95% CI, 6.2-46.3]), respectively, during weeks 9 through 12 and 28% vs 4% (aOR, 11.0 [95% CI, 3.1-38.8]) during weeks 9 through 24.1
“What surprised me was how ineffective both behavioral therapy arms were without a medication and the huge difference that adding a medication made,” Dr. Evins said. “We imagined that because the study population had only been using [nicotine vapes] for a short time due to their young age, they may be able to quit more easily.”
The rate of treatment-emergent adverse events was common but mostly mild nausea, vomiting, and cold symptoms, and was similar across the groups: 86% in the varenicline group, 79% in the placebo group, and 79% in the enhanced usual care group. Discontinuations due to side effects were rare (2% for varenicline; 1% for placebo).
Burton L. Lesnick, MD, a pediatric pulmonologist with Children’s Healthcare of Atlanta, said the findings help clinicians understand that varenicline is effective for nicotine withdrawal when the delivery method is vaping. “Most clinicians suspected that would be the case, but it had not previously been studied,” he said. “Previous studies have not demonstrated efficacy in patients 16 years of age or lower. As vaping is not uncommon in 12- to 16-year-olds, we need better options for that age group.”
Dr. Evins said that in younger teens who are addicted to nicotine vaping, she would expect similar findings. She and her colleagues recently launched a study of behavioral interventions for nicotine vaping cessation in teens ages 14 to 18 years old. What remains elusive, she added, is the point at which a teen’s experimentation with vaping turns into addiction.
References
1. Evins AE, Cather C, Reeder HT, et al. Varenicline for youth nicotine vaping cessation: a randomized clinical trial. JAMA. 2025;333(21):1876-1886. doi:10.1001/jama.2025.3810
