Charleston, SC—For many cigarette smokers, the habit began before they turned age 21 years. Yet few trials have looked at smoking-cessation medication in adolescents and younger adults.
A report in JAMA Pediatrics discusses the results of randomized clinical trial of volunteer participants testing the effectiveness of varenicline in helping them to quit smoking.
“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,” Medical University of South Carolina–led researchers point out. “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.”
To remedy that, the study team sought to evaluate the efficacy and safety of varenicline tartrate for smoking cessation in adolescents and young adults. The two-group randomized, placebo-controlled, double-blind intention-to-treat clinical trial enrolled a volunteer sample of 157 treatment-seeking adolescent and young adult cigarette smokers—ranging in age from 14 to 21 years—at an outpatient clinical site in Charleston, South Carolina, from August 15, 2012, to October 20, 2017. Follow-up lasted until January 25, 2018, with analysis until the following August.
The FDA approved the drug, marketed as Chantix, in 2006 for use in adults aged 18 years or older.
For the trial, 77 participants were randomized in a 1:1 ratio to a 12-week course of varenicline, with 80 receiving placebo. In addition, all participants received weekly smoking-cessation counseling.
Defined as the primary efficacy outcome was urine cotinine level–confirmed 7-day abstinence at the end of treatment, while secondary efficacy outcomes included weekly abstinence throughout active treatment, abstinence at posttreatment follow-up visits, and time to first 7-day abstinence. Researchers also tracked treatment-related adverse events.
Results indicate 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). In terms of secondary outcomes, however, 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).
Researchers also report that 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 versus 60 [75.0%] in the placebo group; RR, 0.95; 95% CI, 0.79-1.15; P = .61).
“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,” the authors conclude. “However, varenicline may hasten abstinence and yield improvements in posttreatment abstinence outcomes.”
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A report in JAMA Pediatrics discusses the results of randomized clinical trial of volunteer participants testing the effectiveness of varenicline in helping them to quit smoking.
“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,” Medical University of South Carolina–led researchers point out. “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.”
To remedy that, the study team sought to evaluate the efficacy and safety of varenicline tartrate for smoking cessation in adolescents and young adults. The two-group randomized, placebo-controlled, double-blind intention-to-treat clinical trial enrolled a volunteer sample of 157 treatment-seeking adolescent and young adult cigarette smokers—ranging in age from 14 to 21 years—at an outpatient clinical site in Charleston, South Carolina, from August 15, 2012, to October 20, 2017. Follow-up lasted until January 25, 2018, with analysis until the following August.
The FDA approved the drug, marketed as Chantix, in 2006 for use in adults aged 18 years or older.
For the trial, 77 participants were randomized in a 1:1 ratio to a 12-week course of varenicline, with 80 receiving placebo. In addition, all participants received weekly smoking-cessation counseling.
Defined as the primary efficacy outcome was urine cotinine level–confirmed 7-day abstinence at the end of treatment, while secondary efficacy outcomes included weekly abstinence throughout active treatment, abstinence at posttreatment follow-up visits, and time to first 7-day abstinence. Researchers also tracked treatment-related adverse events.
Results indicate 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). In terms of secondary outcomes, however, 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).
Researchers also report that 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 versus 60 [75.0%] in the placebo group; RR, 0.95; 95% CI, 0.79-1.15; P = .61).
“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,” the authors conclude. “However, varenicline may hasten abstinence and yield improvements in posttreatment abstinence outcomes.”
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