Varenicline for Youth Nicotine Vaping Cessation: A Randomized Clinical Trial.

IMPORTANCE

Electronic cigarette use (vaping) among adolescents and young adults is common. Few treatments have been tested in this population.

OBJECTIVE

To evaluate the efficacy of varenicline for nicotine vaping cessation in youth who do not smoke tobacco regularly.

DESIGN, SETTING, AND PARTICIPANTS: A 3-group randomized clinical trial compared 12 weeks of double-blind varenicline vs placebo, each added to brief, remotely delivered behavioral counseling and compared with single-blind enhanced usual care, with monthly follow-up to 24 weeks. The trial was conducted among youth, aged 16 to 25 years, who vaped nicotine daily or near daily, did not regularly smoke tobacco, and wanted to reduce or quit vaping, in a single US state from June 2022 to May 2024. Data collection ended May 28, 2024.

INTERVENTIONS

Participants were randomized (1:1:1) to 12 weeks of varenicline titrated to 1 mg twice daily over 7 days (standard titration), weekly counseling, and referral to text messaging vaping cessation support (This is Quitting [TIQ]) (n = 88); identical placebo, weekly counseling, and referral to TIQ (n = 87); or enhanced usual care (referral to TIQ only) (n = 86).

MAIN OUTCOMES AND MEASURES

Biochemically verified continuous vaping abstinence for the last 4 weeks of varenicline treatment vs placebo (primary outcome). Secondary outcomes included bioverified continuous abstinence from weeks 9 through 24 in the varenicline and placebo groups. Additional analyses compared varenicline group and placebo group with enhanced usual care.

RESULTS

Of 261 randomized participants (mean age, 21.4 years; 53% female), 254 completed the trial (97.3%). For varenicline and placebo, continuous abstinence rates were 51% vs 14% during weeks 9 through 12 (adjusted odds ratio [aOR], 6.5 [95% CI, 3.0-14.1]; P < .001) and 28% vs 7% during weeks 9 through 24 (aOR, 6.0 [95% CI, 2.1-16.9]; P < .001). Varenicline had higher continuous abstinence rates vs enhanced usual care during weeks 9 through 12 (51% vs 6%; aOR, 16.9 [95% CI, 6.2-46.3]) and during weeks 9 through 24 (28% vs 4%; aOR, 11.0 [95% CI, 3.1-38.8]). Continuous abstinence rates were not significantly different between the placebo and enhanced usual care groups. Study medication was generally well tolerated. Two varenicline participants (2%) and 1 placebo participant (1%) discontinued study medications due to adverse events. No drug-related serious adverse events occurred. Treatment-emergent adverse events were reported by 76 (86%) in the varenicline group, 68 (79%) in the placebo group, and 68 (79%) in the enhanced usual care group.

CONCLUSIONS AND RELEVANCE

Varenicline, combined with behavioral counseling, increased vaping abstinence in youth who vape nicotine and do not regularly smoke tobacco.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05367492.