VapingVIANCT06765291
Behavioral Intervention for Youth to Promote Vaping Cessation
A study testing QuitVaping and This is Quitting (TIQ) in people with Vaping and Vaping Teens, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Vaping, Vaping Teens, Nicotine Dependence
- What is being tested?
- QuitVaping and This is Quitting (TIQ)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114
Boston, Massachusetts, 02114
Julia Jashinski, MSW, 617-643-1984, jjashinski@mgh.harvard.edu
A. Eden Evins, MD, MPH
About this study
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.
Read the detailed description
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.
- Conditions
- Vaping, Vaping Teens, Nicotine Dependence
- Being tested
- QuitVaping, This is Quitting (TIQ)
- Keywords
- Vaping, Nicotine Depedence, Vaping Cessation
- Medical subject headings
- Vaping, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuitVapingBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| QuitVaping (QV) | Experimental | 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 Receives: Behavioral: QuitVaping; Behavioral: This is Quitting (TIQ) |
| Enhanced Usual Care (EUC) | Active comparator | 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 Receives: Behavioral: This is Quitting (TIQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From week 9 to week 12
Secondary 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.
Measured: From week 9 to week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start18 Jun 2025
- Primary completion21 Feb 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VapingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Anne Eden Evins, Massachusetts General Hospital
- Investigators
- A. Eden Evins, MD, MPH, Principal investigator, Massachusetts General HospitalRandi M. Schuster, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765291
- Sponsor's protocol ID
- 24-560
- Other IDs
- R01CA287721
- Acronym
- VIA
- Status last verified
- Jul 2026
- First submitted
- 3 Jan 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Intervention for Youth to Promote Vaping Cessation
- ClinicalTrials.gov ID
- NCT06765291
- Acronym / sponsor ID
- VIA / 24-560
- Conditions
- Vaping, Vaping Teens, Nicotine Dependence
- Keywords
- Vaping, Nicotine Depedence, Vaping Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 21 Feb 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QuitVaping (QV) | Experimental | Behavioral: QuitVaping, Behavioral: This is Quitting (TIQ)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 |
| Enhanced Usual Care (EUC) | Active comparator | 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 |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
- Able to understand study procedures and read and write in English or Spanish
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuitVapingQuitVaping 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. | Behavioural | QuitVaping (QV) |
| 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. | Behavioural | Enhanced Usual Care (EUC), QuitVaping (QV) |
Primary outcome
Continuous 4-week nicotine vaping abstinence at end of treatment
Time frame: From week 9 to week 12
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.
1 secondary outcome
Continuous continine-verified nicotine vaping abstinence at the end of follow up (Weeks 9-36)
Time frame: From week 9 to week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
A. Eden Evins, MD, MPH principal investigator
Massachusetts General Hospital
Randi M. Schuster, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QuitVaping and This is Quitting (TIQ) in people with Vaping and Vaping Teens, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact A. Eden Evins, MD, MPH (617-643-4679, aeevins@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous 4-week nicotine vaping abstinence at end of treatment (time frame: From week 9 to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.