Treatment-seeking adolescent and young adult cigarette smokers aged 14 to 21 years given varenicline fared no better than those given placebo at end-of-treatment abstinence, according to the results of a study published in JAMA Pediatrics.

The primary efficacy outcome of cotinine level-confirmed 7-day abstinence was compared between groups of treatment-seeking adolescent and young adult cigarette smokers aged 14 to 21 years who were randomly assigned to receive either varenicline tartrate or placebo along with weekly smoking cessation counseling for 12 weeks. Secondary outcomes included weekly abstinence throughout active treatment, abstinence at posttreatment follow-up visits, and time to first 7-day abstinence.

Of 206 individuals screened for study inclusion, 157 met the inclusion criteria and were enrolled as study participants. Among these 157 participants, 59.9% were male and the mean age was 19.1 years. The end-of-treatment (week 12) visit was attended by 90 participants (45 varenicline and 45 placebo group participants). Participants who did not attend the visit were not significantly different on any baseline measures.

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Cotinine-confirmed 7-day abstinence at the end of treatment was not statistically significantly different between the randomized groups. However, participants in the varenicline group achieved self-reported earlier abstinence of at least 7 days (hazard ratio, 1.91; 95% CI, 1.12-3.27) and demonstrated higher rates of self-reported weekly abstinence during the full course of treatment (risk ratio, 1.82; 95% CI, 1.01-3.28; P =.02)

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“[These findings] indicate that varenicline, when added to brief smoking cessation counseling, is adequately tolerated but does not promote end-of-treatment abstinence compared with placebo among adolescent and young adult cigarette smokers,” the researchers wrote. “However, secondary findings suggest that varenicline may promote abstinence early in treatment and increase abstinence at posttreatment follow-up.”


Gray KM, Baker NL, McClure EA, et al. Efficacy and safety of varenicline for adolescent smoking cessation: a randomized clinical trial [published October 14, 2019]. JAMA Pediatr. doi:10.1001/jamapediatrics.2019.3553