Varenicline for Nicotine Vaping Cessation in Adolescents

PHASE4CompletedINTERVENTIONAL
Enrollment

261

Participants

Timeline

Start Date

June 22, 2022

Primary Completion Date

March 20, 2024

Study Completion Date

May 28, 2024

Conditions
VapingNicotine Dependence
Interventions
DRUG

Double Blind Varenicline

"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"

DRUG

Double Blind Placebo

"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"

BEHAVIORAL

QuitVaping

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.

BEHAVIORAL

This Is Quitting

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.

Trial Locations (1)

02114

Center for Addiction Medicine, Boston

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Massachusetts General Hospital

OTHER