Efficacy and Safety of Varenicline for Adolescent Smoking Cessation: A Randomized Clinical Trial | Adolescent Medicine | JAMA Pediatrics | JAMA Network
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    Original Investigation
    October 14, 2019

    Efficacy and Safety of Varenicline for Adolescent Smoking Cessation: A Randomized Clinical Trial

    Author Affiliations
    • 1Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston
    • 2Department of Public Health Sciences, Medical University of South Carolina, Charleston
    • 3Department of Health Sciences and Research, Medical University of South Carolina, Charleston
    JAMA Pediatr. 2019;173(12):1146-1153. doi:10.1001/jamapediatrics.2019.3553
    Key Points

    Question  Is varenicline tartrate, when added to brief cessation counseling, efficacious and safe for smoking cessation in adolescents?

    Findings  In this 12-week randomized clinical trial with 157 treatment-seeking adolescent cigarette smokers, abstinence rates at the end of treatment (primary outcome) did not differ between groups, but examination of secondary findings revealed that varenicline participants achieved abstinence earlier and had higher rates of overall abstinence during treatment and at posttreatment follow-up compared with placebo participants. Treatment-emergent adverse events did not differ between groups.

    Meaning  Compared with placebo, varenicline was well tolerated but did not support improved end-of-treatment abstinence for adolescent smokers.


    Importance  Cigarette smoking is the leading cause of preventable morbidity and mortality in the United States and worldwide, and most tobacco users begin smoking in adolescence. Although advances have yielded efficacious pharmacotherapies to complement smoking cessation counseling in adults, far less progress has been made in addressing tobacco use in adolescence.

    Objective  To evaluate the efficacy and safety of varenicline tartrate for smoking cessation in adolescents and young adults.

    Design, Setting, and Participants  This 2-group randomized, placebo-controlled, double-blind intention-to-treat clinical trial enrolled a volunteer sample of treatment-seeking adolescent and young adult cigarette smokers (n = 157) aged 14 to 21 years at an outpatient clinical site in Charleston, South Carolina, from August 15, 2012, to October 20, 2017. Follow-up was completed on January 25, 2018. Data were analyzed from March 19, 2018, to August 11, 2018, with further revisions completed April 10, 2019.

    Interventions  Participants were randomized in a 1:1 ratio to a 12-week course of varenicline (n = 77) or placebo (n = 80). All participants received weekly smoking cessation counseling.

    Main Outcomes and Measures  The preselected primary efficacy outcome was urine cotinine level–confirmed 7-day abstinence at the end of treatment. Secondary efficacy outcomes included weekly abstinence throughout active treatment, abstinence at posttreatment follow-up visits, and time to first 7-day abstinence. The primary safety outcome was the frequency of treatment-emergent adverse events.

    Results  A total of 157 participants were enrolled (94 male [59.9%]; mean [SD] age, 19.1 [1.5] years). The varenicline and placebo groups did not differ in the primary outcome of cotinine-confirmed self-reported 7-day abstinence at the end of treatment (varenicline group, 4 of 45 [8.9%]; placebo group, 4 of 45 [8.9%]; risk ratio [RR], 0.97; 95% CI, 0.29-2.99; P = .96). However, among secondary outcomes, 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 (RR, 1.81; 95% CI, 1.09-2.99; P = .02) and at posttreatment follow-up (RR, 1.82; 95% CI, 1.01-3.28; P = .02). Study medication was generally well tolerated, and treatment-emergent adverse events did not differ between groups (any adverse events, 55 [71.4%] in the varenicline group vs 60 [75.0%] in the placebo group; RR, 0.95; 95% CI, 0.79-1.15; P = .61).

    Conclusions and Relevance  When added to weekly cessation counseling for adolescent cigarette smokers, varenicline, compared with placebo, was well tolerated but did not improve end-of-treatment abstinence. However, varenicline may hasten abstinence and yield improvements in posttreatment abstinence outcomes.

    Trial Registration  ClinicalTrials.gov identifier: NCT01509547