Varenicline and counseling for vaping cessation: a double-blind, randomized, parallel-group, placebo-controlled trial

Abstract

Background Vaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and outcomes for people who use electronic cigarettes (EC) and want to quit. The objective is to evaluate the efficacy and safety of varenicline (1 mg BID, administered for 12 weeks, with follow-up to week 24) combined with vaping cessation counseling in exclusive daily EC users intending to quit vaping. Methods Design: Double-blind, randomized, parallel-group, placebo-controlled trial. Setting: The study took place at a University-run smoking cessation center. Participants: People who exclusively use ECs daily and intend to quit vaping. Intervention: A total of 140 subjects were randomized to either varenicline (1 mg, administered twice daily for 12 weeks) plus counseling or placebo treatment (administered twice daily, for 12 weeks) plus counseling. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up, nontreatment phase. Main outcomes and measures: The primary efficacy endpoint of the study was biochemically validated continuous abstinence rate (CAR) at weeks 4 to 12. Secondary efficacy end points were CAR at weeks 4 to 24 and 7-day point prevalence of vaping abstinence at weeks 12 and 24. Results CAR was significantly higher for varenicline vs placebo at each interval: weeks 4–12, 40.0% and 20.0%, respectively (OR = 2.67, 95% CI = [1.25–5.68], P = 0.011); weeks 4–24, 34.3% for varenicline with counseling and 17.2% for placebo with counseling (OR = 2.52, 95% CI = [1.14–5.58], P = 0.0224). The 7-day point prevalence of vaping abstinence was also higher for the varenicline than placebo at each time point. Serious adverse events were infrequent in both groups and not treatment-related. Conclusions The findings of the present RCT indicate that inclusion of varenicline in a vaping cessation program for people who use electronic cigarettes and intending to quit may result in prolonged abstinence. These positive findings establish a benchmark of intervention effectiveness, may support the use of varenicline combined with counseling in vaping cessation programs, and may also help guiding future recommendations by health authorities and healthcare providers. Trial registration The study has been registered in EUDRACT with Trial registration ID: 2016-000339-42.

Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes

“…To our knowledge, it is the first trial to test cytisinicline for this indication, and it did so using a new dosing regimen with demonstrated smoking cessation efficacy in a US population . The only previously reported placebo-controlled randomized vaping cessation trial tested varenicline, a smoking cessation aid whose mechanism of action resembles cytisinicline . Both trials administered drugs for 12 weeks, accompanied by behavioral support, and assessed cotinine-verified abstinence vs placebo at the end of treatment and after treatment ended.…”

“… The only previously reported placebo-controlled randomized vaping cessation trial tested varenicline, a smoking cessation aid whose mechanism of action resembles cytisinicline. Both trials administered drugs for 12 weeks, accompanied by behavioral support, and assessed cotinine-verified abstinence vs placebo at the end of treatment and after treatment ended. Varenicline’s end-of-treatment OR of 2.67 (95% CI, 1.25-5.68) resembles cytisinicline’s OR of 2.64 (95% CI, 1.06-7.10) in this trial.…”

“…17 The only previously reported placebo-controlled randomized vaping cessation trial tested varenicline, a smoking cessation aid whose mechanism of action resembles cytisinicline. 8 Both trials administered drugs for 12 weeks, accompanied by behavioral support, and assessed cotinine-verified abstinence vs placebo at the end of a Abstinence from e-cigarette smoking was defined as a self-report of no cigarettes since last visit that was confirmed by a saliva cotinine level less than 10 ng/mL. Participants with a saliva cotinine level higher than 10 ng/mL or missing outcome data were counted as not abstinent from e-cigarettes.…”

“…7 Evidence from clinical trials to guide vaping cessation treatment, especially pharmacotherapy, is limited. [8][9][10][11][12][13] Varenicline demonstrated efficacy for e-cigarette cessation among adults in a randomized trial, 8 and a pilot trial suggested efficacy for nicotine replacement. 9 No medication has approval from the US Food and Drug Administration for vaping cessation.…”

Time for a Focus on Cessation of E-Cigarettes

“…To date, and to our knowledge, only 1 full-scale trial has evaluated medication for cessation of e-cigarette use. In a 12week randomized clinical trial in Europe among 140 older adults who exclusively used e-cigarettes, 4 the biochemically validated continuous abstinence rate during weeks 4 to 12 was 40% among those receiving varenicline (1 mg orally twice daily for 12 weeks) compared with 20% among those receiving placebo.…”