An interventional study of QuitVaping and This is Quitting (TIQ) in Vaping, Vaping Teens and Nicotine Dependence, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 14 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
Up to 400 adolescents, ages 14-19, who report weekly nicotine vaping (or use of other non combusted nicotine products, "vaping") and are willing to try to quit or reduce vaping will be enrolled; eligible participants will be randomly assigned in a 1:1 ratio to a double-blind intervention consisting of (1) QuitVaping intervention plus texting support or (2) EUC only.
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. Written informed assent will be obtained from participants ages 16-17, no parental consent required. An opt-out consent form will be sent to a parent or legal guardian of participants ages 14-15. 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.
402 studies on the registry are indexed under Vaping; 95 are open to participants now.
This study's planned enrollment of 400 is above the median of 79 across 322 interventional studies indexed under Vaping.
Browse Vaping studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Behavioral: QuitVaping · Behavioral: This is Quitting (TIQ)
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
Behavioral: This is Quitting (TIQ)
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.
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 12
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 36
Plan to share: Yes — IPD will be deposited in the NIMH Data Archive. This is a free data repository open to qualified researchers from all mental health and other research communities to share, archive, cite, access, and explore research data. Clinical data necessary to validate and replicate research findings, including questionnaires, interviews, and saliva cotinine test results will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Scientific data will be available one year after the grant end date specified on the first Notice of Award. Scientific data included in published manuscripts will be made available at the time of publication. Scientific data and the code/software/tools used to development the published or submitted dataset will be shared at the time of data submission or publication and maintained for no shorter than five years.
Access criteria: Data access will be controlled. In order to access shared data, qualified researchers will be required to complete a data use certification and receive approval from NDA Data Access Committee.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Feb 2029, 44 months after the start.
Of 184 non-industry interventional studies with no phase under Vaping, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 44 months is above that.
Counting every sponsor, half of 208 studies reached it within 18 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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