At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Trial of Varenicline for Cessation of Nicotine Vaping in Adolescent Non-smokers
In Brief
A Phase 4 clinical trial evaluating Double Blind Varenicline, Double Blind Placebo, and 2 other interventions for Vaping and Nicotine Dependence. Completed, enrolled 261 participants across 1 site.
Detailed Summary
The study will test the hypothesis that varenicline, when added to behavioral and texting support for vaping cessation, will improve vaping abstinence rates in adolescents dependent on vaped nicotine over placebo plus behavioral and texting support for vaping cessation. Approximately 225 adolescents will be randomly assigned to one of three arms (1) varenicline up to 1 mg bid for 12 weeks plus behavioral and texting support for vaping cessation (V+BC), (2) identical appearing placebo plus behavioral and texting support (P+BC) and (3) enhanced usual care (EUC). The primary comparison will be the double-blind, placebo-controlled comparison of vaping cessation rates in those assigned to varenicline vs placebo.
Study Details
Timeline
Interventions
For participants 16-17 years old, ≤ 55 kg: * 0.5 mg once daily for 7 days, then * 0.5 mg twice daily for 11 weeks For participants 16-17 years old, \>55 kg: * 0.5 mg once daily or 3 days, * 0.5 mg twice daily for 4 days * 1.0 mg twice daily for 11 weeks For participants 18+ years old: * 0.5 mg once daily or 3 days, * 0.5 mg twice daily for 4 days * 1.0 mg twice daily for 11 weeks
For participants 16-17 years old, ≤ 55 kg: * 0.5 mg once daily for 7 days, then * 0.5 mg twice daily for 11 weeks For participants 16-17 years old, \>55 kg: * 0.5 mg once daily or 3 days, * 0.5 mg twice daily for 4 days * 1.0 mg twice daily for 11 weeks For participants 18+ years old, regardless of weight: * 0.5 mg once daily or 3 days, * 0.5 mg twice daily for 4 days * 1.0 mg twice daily for 11 weeks
QuitVaping is a manualized intervention based on the American Lung Association smoking cessation program modified with adolescent appropriate content and language for vaping cessation from the vaping section of teen.smokefree.gov and the Truth Initiative. These behavioral support sessions will be delivered weekly during the 12-week treatment phase via videoconference or in- person.
A free, publicly available text message vaping cessation program from Truth Initiative, designed specifically to help adolescents who vape nicotine quit. Participants who set a quit date receive messages for a week preceding it and 30 days afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting and cutting down to quit.