Randomized Controlled Trial of Varenicline for Cessation of Nicotine Vaping in Adolescent Non-Smokers
Varenicline is a medicine used to help people cease smoking. Behavioral counseling as well as text…..are also options that people utilize to cease smoking. This project explores how varenicline combined with behavioral and texting support can be more effective when utilized together, to help adolescents stop vaping.
PROJECT STATUS
This project is currently in developing the manuscript.
AIMS
This project aims to test the hypothesis that varenicline added to behavioral and texting support will be well tolerated and improve vaping cessation rates over behavioral treatment and texting support and over monitoring only in nicotine dependent adolescents who vape, do not smoke regularly, and are willing to try treatment to stop vaping. Varenicline efficacy and tolerability with behavioral and texting support will be evaluated, as will group differences in consumption of alcohol, combusted tobacco, cannabis, and non-medical prescription drugs during the treatment and follow-up periods.
METHODS
The recruitment goal for this study is to enroll 300 participants (and randomize 240) who meet the following criteria: (1) Are between the ages of 16 and 25, (2) Are self-reported daily or near-daily nicotine vapers over the past three months with a bio-verified positive cotinine result at enrollment, (3) Report signs of nicotine dependence, (4) Are willing to try varenicline to stop vaping, (5) Demonstrate an ability to understand study procedures and can read and write in English, (6) Are competent and willing to provide informed consent (or have parents who demonstrate this ability if subject is younger than 18), (7) Have a parent or legal guardian who is able and willing to provide written informed consent (if the subject is under 18 years old), and (8) For female participants, have a negative pregnancy test at enrollment as well as agreement to use effective contraception during the study.
For behavioral and texting support, participants will attend QuitVaping behavioral support sessions, completed in-person or via videoconferencing, once per week for 12 weeks and be encouraged to sign up for This is Quitting (TIQ), a text message vaping cessation program for adolescents.
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.
This is Quitting is 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.
300 adolescents with tobacco use disorder were enrolled and randomized into the following: 1) varenicline standard titration, 2) placebo for 12 weeks, or 3) 12 weekly behavioral counseling sessions with or without a referral to TIQ text messaging support. Most participants completed the trial.
RESULTS
Preliminary results suggest that varenicline, in combination with behavioral counseling for vaping cessation delivered by lay counselors could significantly improve vaping abstinence over behavioral counseling alone and text support. Additional results will be shared once the manuscript has been published.
COE PROJECT STAFF
A. Eden Evins, MD, MPH
CO-PRINCIPAL INVESTIGATOR
Corinne Cather, PhD
CLINICAL SITE SUPERVISOR
Additional Collaborators
Co-Principal Investigator: Randi Schuster, PhD
Funding
Funding for this project was provided by the National Institutes of Health – National Institute on Drug Abuse.