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VapingPhase 4ViVANCT05367492

Varenicline for Nicotine Vaping Cessation in Adolescents

A Phase 4 study testing Double Blind Varenicline, QuitVaping and This Is Quitting in people with Vaping and Nicotine Dependence, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will test the hypothesis that varenicline, when added to behavioral and texting support for vaping cessation, will improve vaping abstinence rates in adolescents dependent on vaped nicotine over placebo plus behavioral and texting support for vaping cessation. Read more about this study

Who is it for?
Ages 16 to 25 years
Conditions the study is for
Vaping, Nicotine Dependence
What is being tested?
Double Blind Varenicline, QuitVaping and This Is Quitting
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
261 participants
Where
1 siteUnited States
Study dates
22 Jun 2022to 28 May 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 16 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Ages 16-25, inclusive;
  • Self-report of daily or near daily nicotine vaping for the prior ≥ 3 months and semi-quantitative saliva screening for cotinine positive for recent nicotine use;
  • Nicotine dependence as defined by a score ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI), or report of persistent use despite negative consequences, or prior failed quit attempts;
  • Self-report of no regular combusted tobacco use in the past 2 months at enrollment and exhaled CO <10 ppm;
  • Total body weight at enrollment ≥35 kg (77 lbs);
  • Report willingness to try varenicline to stop vaping;
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  • Able to understand study procedures and read and write in English;
  • Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18);
  • Competent and willing to provide written informed consent (if age 18+) or assent (if under 18);
  • For participants who could become pregnant: negative urine pregnancy test at enrollment and agree to use effective contraception (e.g., abstinence, hormonal contraception, intra-uterine device, sterilization, or double barrier contraception) during the study.

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;
  • Unstable medical condition, epilepsy, severe renal impairment;
  • Inpatient psychiatric hospitalization in the prior 6 months, serious suicidal ideation or suicide attempt within 6 months of enrollment, recent active suicidal ideation or suicidal behavior identified at enrollment or baseline visits;
  • Evidence of active problem substance use severe enough to compromise ability to safely participate, in the investigator's opinion;
  • Prior adverse drug reaction to varenicline;
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  • Unwilling to provide 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;
  • Ward of the state.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Addiction Medicine

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Randomized Controlled Trial of Varenicline for Cessation of Nicotine Vaping in Adolescent Non-smokers

The study will test the hypothesis that varenicline, when added to behavioral and texting support for vaping cessation, will improve vaping abstinence rates in adolescents dependent on vaped nicotine over placebo plus behavioral and texting support for vaping cessation. Approximately 225 adolescents will be randomly assigned to one of three arms (1) varenicline up to 1 mg bid for 12 weeks plus behavioral and texting support for vaping cessation (V+BC), (2) identical appearing placebo plus behavioral and texting support (P+BC) and (3) enhanced usual care (EUC). The primary comparison will be the double-blind, placebo-controlled comparison of vaping cessation rates in those assigned to varenicline vs placebo.

Read the detailed description

Up to 300 adolescents, aged 16-25, who vape, do not smoke regularly, and want to quit vaping will be consented; approximately 225 eligible participants will be randomly assigned to a double blind, placebo-controlled intervention consisting of (1) varenicline or (2) identical placebo, up to 1 mg bid for 12 weeks, plus behavioral and texting support for adolescent vaping cessation or to (3) enhanced usual care. The primary comparison of interest is the double blind, placebo-controlled efficacy comparison of those assigned to (1) varenicline vs (2) placebo on vaping abstinence outcomes. The secondary comparison of placebo plus behavioral and texting support vs. EUC will estimate the efficacy of behavioral and texting support for vaping cessation in this population. The secondary comparison of varenicline plus behavioral and texting support vs EUC will estimate of the efficacy of varenicline treatment plus behavioral and texting support for vaping cessation in this population vs no treatment, the most common vaping cessation intervention. All participants will complete enrollment and baseline visits, and six monthly assessment visits. Those assigned to double blind intervention (study arms 1 or 2) will also complete 12 weekly behavioral support sessions. Assessors will be blind to intervention assignment (arm 1 or 2) vs EUC (arm 3) assignment. Among those assigned to the V+BC or P+BC intervention arms, study staff and participants will be blind to active varenicline vs placebo assignment, such that among those assigned to intervention (arm 1 or 2), assignment to study drug will be double blind. For those assigned a double blind intervention arm, study staff will distribute varenicline or identical appearing placebo and give instructions use at weeks 0, 2, 4 and 8. Participants will be asked to bring all empty and unused study medication at each in-person study visit through Week 12. The enrollment visit will consist of questionnaires, diagnostic assessments, vitals, saliva and urine samples. The baseline visit will consist of questionnaires, a saliva sample for cotinine concentration, and randomization. Monthly visits will consist of interviews, questionnaires and a saliva and urine sample. Weekly treatment meetings for participants assigned to arms 1 or 2 will consist of cognitive behavioral support and questionnaires.

Being tested
Double Blind Varenicline, Double Blind Placebo, QuitVaping, This Is Quitting
Keywords
Vaping, Nicotine, Adolescents, Cessation, Varenicline
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.

  • Double Blind VareniclineDrug

    For participants 16-17 years old, ≤ 55 kg:

    • 0.5 mg once daily for 7 days, then
    • 0.5 mg twice daily for 11 weeks

    For participants 16-17 years old, >55 kg:

    • 0.5 mg once daily or 3 days,
    • 0.5 mg twice daily for 4 days
    • 1.0 mg twice daily for 11 weeks

    For participants 18+ years old:

    • 0.5 mg once daily or 3 days,
    • 0.5 mg twice daily for 4 days
    • 1.0 mg twice daily for 11 weeks

  • Double Blind PlaceboDrug

    For participants 16-17 years old, ≤ 55 kg:

    • 0.5 mg once daily for 7 days, then
    • 0.5 mg twice daily for 11 weeks

    For participants 16-17 years old, >55 kg:

    • 0.5 mg once daily or 3 days,
    • 0.5 mg twice daily for 4 days
    • 1.0 mg twice daily for 11 weeks

    For participants 18+ years old, regardless of weight:

    • 0.5 mg once daily or 3 days,
    • 0.5 mg twice daily for 4 days
    • 1.0 mg twice daily for 11 weeks

  • 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 QuittingBehavioural

    Also called 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.

Study groups in NCT05367492
Study groupRoleWhat they receive
Double Blind Varenicline (V + BC)ExperimentalParticipants will... * Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, 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: Drug: Double Blind Varenicline; Behavioral: QuitVaping; Behavioral: This Is Quitting
Double Blind Placebo (P + BC)Placebo comparatorParticipants will... * Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. * Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, 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: Drug: Double Blind Placebo; Behavioral: QuitVaping; Behavioral: This Is Quitting
Single Blind Enhanced Usual Care (EUC)Active comparatorParticipants will... * Receive NO drug intervention. * Attend NO behavioral support sessions. * Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.
Receives: Behavioral: This Is Quitting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Continuous 4-week Nicotine Vaping Abstinence at End of Treatment (Weeks 9-12)

    Point-prevalence abstinence from e-cigarette use was defined as self-report of no e-cigarette use since the last visit, bioverified by saliva cotinine <30 ng/ml. Continuous abstinence is defined as observed point-prevalence abstinence over specified study visits at weeks 9, 10, 11 and 12. Visits with self-reported abstinence missing bioverification were treated as missing, with missingness addressed via multiple imputation.

    Measured: Assessments at study weeks 9, 10, 11, and 12

Secondary outcomes (6)

  1. Seven-Day Point-Prevalence Nicotine Vaping Abstinence at End of Treatment (Week 12)

    Point-prevalence abstinence from e-cigarette use was defined as self-report of no e-cigarette use since the last visit, bioverified by saliva cotinine <30 ng/ml. Visits with self-reported abstinence missing bioverification were treated as missing, with missingness addressed via multiple imputation.

    Measured: Study week 12

  2. Continuous Nicotine Vaping Abstinence Over Study Weeks 9 to 24

    Point-prevalence abstinence from e-cigarette use was defined as self-report of no e-cigarette use since the last visit, bioverified by saliva cotinine <30 ng/ml. Continuous abstinence defined as observed point-prevalence abstinence over specified study visits at weeks 9, 10, 11, 12, 16, 20, and 24. Visits with self-reported abstinence missing bioverification were treated as missing, with missingness addressed via multiple imputation.

    Measured: Study weeks 9, 10, 11, 12, 16, 20, 24

  3. Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12)

    Minnesota Nicotine Withdrawal Scale (MNWS) total scores over study weeks 1 to 12. The MNWS is an 8-item measure assessing the severity of nicotine withdrawal symptoms. Items are scored on an ordinal scale from 0 ("not at all") to 4 ("extreme") with total scores ranging from 0 to 32. Higher scores indicate greater severity of nicotine withdrawal symptoms. Missingness due to missed visits and/or dropout was addressed via multiple imputation.

    Measured: Study weeks 1-12

  4. Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12)

    Summed scores from the Questionnaire of Vaping Craving (QVC) over Study Weeks 1 to 12. The QVC is a 10-item self-rated validated measure (ranging from 10 to 70) of vaping craving that examines desire and intent to vape and anticipation of positive outcomes related to e-cigarette use, with higher scores indicating greater cravings to vape. Missingness due to missed visits and/or dropout are addressed with multiple imputation.

    Measured: Study weeks 1-12

  5. Mood and Anxiety Symptoms Questionnaire (MASQ-D30) General Distress Subscore (Weeks 4, 8, and 12)

    Summed scores from the General Distress Subscale of the 30-Item Mood and Anxiety Symptoms Questionnaire (MASQ-D30) over Study Weeks 4,8, and 12. The General Distress subscale of the MASQ-D30 is a 10-item self-rated validated measure (ranging from 10 to 50) of non-specific symptoms of general distress or negative affect, with higher scores indicating a greater degree of general distress. Missingness due to missed visits and/or dropout was addressed with multiple imputation.

    Measured: Study weeks 4, 8, 12

  6. Neuropsychiatric Adverse Event Inventory (NAEI) Elicited Adverse Events by Week 12

    The Neuropsychiatric Adverse Event Inventory (NAEI) is a structured interview used to assess neuropsychiatric adverse events. This outcome reports on the number of participants who reported at least one adverse event on the NAEI between the first study week (Week 1) to the end of treatment (Week 12).

    Measured: Study weeks 1-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2022
  2. Study start22 Jun 2022
  3. Primary completion20 Mar 2024
  4. Study completion28 May 2024

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Up to 300 participants will be consented and approximately 225 participants will be randomized in a double blind, placebo-controlled, parallel-group trial comparing vaping abstinence rates in participants randomly assigned to (1) varenicline added to behavioral and texting support for vaping cessation (V+BC) and (2) identical placebo added to behavioral and texting support for vaping cessation (P+BC) (primary comparison). Exploratory secondary comparisons will be made between double blind arms 1 and 2 and the single blind (3) enhanced usual care arm.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05367492
Sponsor's protocol ID
2020P002774
Other IDs
R01DA052583
Acronym
ViVA
Status last verified
Apr 2025
First submitted
4 May 2022
Last updated
27 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of this study are available upon request. Data will include de-identified individual patient-level data, a data dictionary, and analytic code. Investigators proposing to use the data must execute a data use agreement with Massachusetts General Hospital and have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, before data is shared. Data will be available within three months of manuscript publication. Requests for data should be sent to aeevins@mgh.harvard.edu or rschuster@mgh.harvard.edu.

Publications

  • Schuster RM, Cather C, Pachas GN, Nielsen L, Iroegbulem V, Dufour J, Potter K, Levy S, Gray KM, Evins AE. A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol. Front Psychiatry. 2023 Mar 15;14:1083791. doi: 10.3389/fpsyt.2023.1083791. eCollection 2023.

    PubMed 37009114

  • Gilman JM, Cather C, Reeder HT, Evohr B, Pachas GN, Gray KM, McClure EA, Schuster RM, Evins AE. Cannabis Use and Nicotine Vaping Cessation Outcomes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2547799. doi: 10.1001/jamanetworkopen.2025.47799.

    PubMed 41385228

  • Evins AE, Cather C, Reeder HT, Evohr B, Potter K, Pachas GN, Gray KM, Levy S, Rigotti NA, Iroegbulem V, Dufour J, Casottana K, Costello MA, Gilman JM, Schuster RM. Varenicline for Youth Nicotine Vaping Cessation: A Randomized Clinical Trial. JAMA. 2025 Jun 3;333(21):1876-1886. doi: 10.1001/jama.2025.3810.

    PubMed 40266580

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Double Blind Varenicline, QuitVaping and This Is Quitting in people with Vaping and Nicotine Dependence, 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 27 Apr 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuous 4-week Nicotine Vaping Abstinence at End of Treatment (Weeks 9-12) (time frame: Assessments at study weeks 9, 10, 11, and 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05367492, which also lists 3 linked publications.

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 27 Apr 2025.

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