Behavioral Intervention for Youth to Promote Vaping Cessation
NCT ID: NCT06765291
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2025-06-18
2028-09-27
Brief Summary
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Detailed Description
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Participants assigned to the QuitVaping intervention will receive referral to TIQ texting app and 12 brief, weekly, study intervention visits with monthly follow up visits until week 36. Those who are assigned to EUC will be offered TIQ texting app referral to support vaping cessation. All participants will receive education about nicotine, vaping and addiction, advice to quit vaping, TIQ referral, and weekly blinded assessments with biochemical verification of abstinence. The person conducting the assessment will be blind to study condition such that the intervention will be double blind. Following completion of the 12-week intervention period, participants will have follow-up visits at weeks 16, 20, 24, 28, 32, and 36. Visits will be conducted remotely on a secure video conferencing platform or in-person.
The enrollment visit will include a detailed description of the study, informed consent/assent, assessments to confirm eligibility, assessments of vaping and other drug use behavior, and medical and psychiatric diagnostic and symptom assessments. Written informed consent will be obtained from participants age 18 years. An opt-out consent form will be sent to a parent or legal guardian of participants ages 14-17. If a parent or legal guardian does not opt their child out within two weeks of verified review of the opt out consent form, the participant is considered consented and written informed assent will be obtained.
Eligible, consented participants will then be scheduled for weekly visits which will include assessments for all participants, and behavioral vaping cessation sessions for those assigned to QuitVaping. Saliva will be collected at assessment visits for cotinine measurement in participants who report nicotine abstinence. Urine NNAL will be collected at week 12 in participants who report continuous 4-week abstinence (weeks 9-12). Instructions for how to perform the tests will be sent to participants, and during virtual assessment visits, participants will hold the assays up to their device's camera so study staff can record the test results.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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QuitVaping (QV)
Participants will:
* Attend QuitVaping behavioral support sessions, completed via videoconference or in-person, once per week for 12 weeks
* Be encouraged to sign up for This is Quitting (TIQ), a text message vaping cessation program for adolescents
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.
This is Quitting (TIQ)
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.
Enhanced Usual Care (EUC)
Participants will:
* Be encouraged to sign up for This is Quitting (TIQ), a text message vaping cessation program for adolescents
* Attend no behavioral support sessions
This is Quitting (TIQ)
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.
Interventions
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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.
This is Quitting (TIQ)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Able to understand study procedures and read and write in English or Spanish
* Have a parent or legal guardian who is able to participate in the opt out process
* Competent and willing to provide written informed consent (if age 18) or assent (if under 18)
Exclusion Criteria
* 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
14 Years
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Anne Eden Evins
Professor of Psychiatry
Principal Investigators
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A. Eden Evins, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Randi M. Schuster, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-560
Identifier Type: -
Identifier Source: org_study_id
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