Behavioral Intervention for Youth to Promote Vaping Cessation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-19
SponsorMassachusetts General Hospital
About this trial
This study will test the hypothesis that the QuitVaping (QV) intervention and additional texting support will improve nicotine abstinence rates in adolescents as compared to Enhanced Usual Care (EUC: education about nicotine, vaping and addiction, advice to quit vaping, referral to TIQ texting support). Approximately 400 adolescents will be randomly assigned to one of two arms (1) QuitVaping intervention plus texting support to quit vaping and (2) EUC only.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 14-19 inclusive
Self-report of at least weekly nicotine vaping (or use of other non combusted nicotine products, "vaping") for the prior ≥3 months
Self-report of no regular combusted tobacco use (i.e., 5 or more days of smoke smoked tobacco use per week) prior to enrollment and exhaled CO <10 ppm for those with an in person baseline visit
Report willingness to try to quit or reduce vaping in the next 30 days
Disqualifiers
Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion)
Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study
Unwilling to provide saliva or urine samples
Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol
Trial design
Design model
Parallel
Treatments tested in this trial
QuitVaping
BehavioralQuitVaping 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 (TIQ)
BehavioralA 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: QuitVaping (QV)Experimental treatment 2 interventions
Group B: Enhanced Usual Care (EUC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Continuous 4-week nicotine vaping abstinence at end of treatment
The percent of participants who self-report nicotine vaping abstinence since the last visit on the timeline followback interview and have cotinine \<10ng/mL, assessed at study weeks 9-12. The primary comparison of interest is between the QV + EUC arms.
Time frame
From week 9 to week 12Secondary outcomes
1
Continuous continine-verified nicotine vaping abstinence at the end of follow up (Weeks 9-36)
The percent of participants who self-report nicotine vaping abstinence since the last visit on the timeline followback interview and have cotinine \<10ng/mL, assessed at study weeks 9-36. The primary comparison of interest is between the QV + EUC arms.
Time frame
From week 9 to week 36Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov