People who wish to quit vaping may find success with the help of varenicline, which has been found in a recent study to result in numerically higher abstinence rates relative to placebo.
“Varenicline appears safe and promising for vaping cessation,” the investigators said. “However, larger randomized controlled trials (RCTs) are needed to confirm its long-term efficacy and safety.”
RCTs comparing varenicline with placebo for vaping cessation were searched in the databases of Medline, Embase, and the Cochrane Library. The most rigorous criterion of biochemically validated vaping abstinence at maximum follow-up served as the primary outcome. Other outcomes included 7-day point prevalence and continuous abstinence at end of treatment and maximum follow-up.
The investigators also assessed any adverse events (AEs) and serious AEs for safety. They estimated the relative risks (RRs) and 95 percent confidence intervals (CIs) using random-effects models.
Three RCTs, comprising 178 participants randomized to varenicline and 177 to placebo, met the eligibility criteria. The mean age of participants ranged from 21‒54 years, and the proportion of males ranged from 46 percent to 51 percent. Treatment duration was 8‒12 weeks, while the maximum follow-up ranged from 12‒24 weeks. [Am J Med 2026;139:475-483]
At maximum follow-up, the pooled RR for varenicline vs placebo for vaping abstinence was 2.20 (95 percent CI, 0.58‒8.36). The use of varenicline also correlated with a twofold increase in 7-day point prevalence abstinence at end of treatment (RR, 2.29, 95 percent CI, 1.21‒4.33) and maximum follow-up (RR, 2.22, 95 percent CI, 1.03‒4.81).
Continuous abstinence
Two trials reported continuous abstinence, with varenicline showing greater rates than placebo at end of treatment (trial 1: 51 percent vs 14 percent; trial 2: 40 percent vs 20 percent) and maximum follow-up (trial 1: 28 percent vs 7 percent; trial 2: 34 percent vs 17 percent).
“Continuous abstinence rates could not be pooled but were higher with varenicline in both reporting trials at the end of treatment and maximum follow-up,” the investigators said.
In terms of safety, varenicline demonstrated an acceptable profile. Most AEs were transient and mild in severity (eg, insomnia, nausea, abnormal dreams). The incidence of serious AEs was low (range: 0‒3 percent), with no deaths recorded.
“These findings support varenicline as a safe and promising pharmacotherapy for vaping cessation, though larger RCTs are needed to establish its safety and efficacy,” the investigators said.
Inconclusive result
The current systematic review and meta-analysis included the study by Fucito and colleagues, which reported wide CIs due to its small sample size (n=40) and employed a shortened 8-week varenicline course. Such inclusion may have influenced the meta-analysis, leading to inconclusive results. [Am J Prev Med 2024;67:296-298]
Unlike the other two trials included, the one conducted by Fucito and colleagues did not report biochemically validated continuous abstinence, which was considered as the most accurate measure. [JAMA 2025;333:1876-1886; BMC Med 2023;21:220]
“Future RCTs should employ the standard 12-week varenicline regimen established through smoking cessation trials,” the investigators said. [Expert Opin Drug Discov 2018;13:671-683]
“Extended treatment durations may further benefit individuals experiencing greater difficulty achieving abstinence,” they added. [Addiction 2009;104:1597-1602; Tuberc Respir Dis (Seoul) 2015;78:92-98; JAMA 2006;296:64-71]