E-cigarette UsePhase 2NCT07040566
A Trial of Varenicline for E-cigarette Cessation
A Phase 2 study testing Varenicline 1mg BID in people with E-cigarette Use and Vaping, run by Yale University at 2 sites in United States.
Trial summary
This is randomized, placebo-controlled clinical trial in treatment-seeking adults who report regular e-cigarette use to test the hypothesis that varenicline is efficacious for quitting e-cigarettes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- E-cigarette Use, Vaping, Nicotine Dependence
- What is being tested?
- Varenicline 1mg BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2025to 30 Oct 2030
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- report daily use of an e-cigarette containing nicotine
- live in Connecticut or South Carolina
Who cannot join
- regular use of other tobacco products besides e-cigarettes
- medical contraindications for varenicline use
- current treatment for tobacco cessation
- lack proficiency in English
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Fatigate, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Hollings Cancer Center at MUSC (HCC)
Charleston, South Carolina, 29425
- Recruiting
Yale Cancer Center/Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06520
About this study
Official title: Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults
This is randomized, placebo-controlled clinical trial in treatment-seeking adults who report regular e-cigarette use to test the hypothesis that varenicline is efficacious for quitting e-cigarettes.
Read the detailed description
Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) or matching placebo plus brief cessation advice from a counselor and self-management resources. All participants will also complete research assessments every 3 weeks during treatment and a final follow-up visit at week 26.
The primary objective is to test the efficacy of varenicline vs. placebo on e-cigarette quit rates. We will also evaluate predictors and moderators of outcomes and explore changes in health biomarkers following e-cigarette cessation treatment.
- Conditions
- E-cigarette Use, Vaping, Nicotine Dependence
- Being tested
- Varenicline 1mg BID, Placebo
- 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.
Varenicline 1mg BIDDrug
12 weeks following the standard titration of 1 mg, twice daily
PlaceboDrug
Matching placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) plus brief cessation advice with a counselor and self-management resources. Receives: Drug: Varenicline 1mg BID |
| Placebo | Placebo comparator | Participants will randomly be assigned to 12-weeks of matching placebo plus brief cessation advice with a counselor and self-management resources. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Abstinent From E-cigarette Use at Week 12
7-day point-prevalence e-cigarette abstinence (PPA) at Week 12 defined as no ecigarette use [and no use of any combusted tobacco product], not even a puff, biochemically verified by saliva cotinine
Measured: Week 12
Secondary outcomes (1)
Number of Participants Abstinent From E-cigarette Use at Week 26
7-day point-prevalence e-cigarette abstinence (PPA) at Week 26 defined as no ecigarette use [and no use of any combusted tobacco product], not even a puff, biochemically verified by saliva cotinine
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start14 Oct 2025
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-cigarette UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adults who report regular e-cigarette use
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa Fucito, PhD, Principal investigator, Yale UniversityBenjamin Toll, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040566
- Sponsor's protocol ID
- 2000038513
- Other IDs
- 1R01CA296186-01
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared to an NIH data repository - the NIMH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults
- ClinicalTrials.gov ID
- NCT07040566
- Acronym / sponsor ID
- 2000038513
- Conditions
- E-cigarette Use, Vaping, Nicotine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Oct 2030 (estimated)
- First posted
- 27 Jun 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 is randomized, placebo-controlled clinical trial in treatment-seeking adults who report regular e-cigarette use to test the hypothesis that varenicline is efficacious for quitting e-cigarettes.
Detailed description
Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) or matching placebo plus brief cessation advice from a counselor and self-management resources. All participants will also complete research assessments every 3 weeks during treatment and a final follow-up visit at week 26.
The primary objective is to test the efficacy of varenicline vs. placebo on e-cigarette quit rates. We will also evaluate predictors and moderators of outcomes and explore changes in health biomarkers following e-cigarette cessation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Adults who report regular e-cigarette use
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: Varenicline 1mg BIDParticipants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) plus brief cessation advice with a counselor and self-management resources. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will randomly be assigned to 12-weeks of matching placebo plus brief cessation advice with a counselor and self-management resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- report daily use of an e-cigarette containing nicotine
- live in Connecticut or South Carolina
Key exclusion criteria (4 listed)
- regular use of other tobacco products besides e-cigarettes
- medical contraindications for varenicline use
- current treatment for tobacco cessation
- lack proficiency in English
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 |
|---|---|---|
| Varenicline 1mg BID12 weeks following the standard titration of 1 mg, twice daily | Drug | Varenicline |
| PlaceboMatching placebo twice daily | Drug | Placebo |
Primary outcome
Number of Participants Abstinent From E-cigarette Use at Week 12
Time frame: Week 12
7-day point-prevalence e-cigarette abstinence (PPA) at Week 12 defined as no ecigarette use [and no use of any combusted tobacco product], not even a puff, biochemically verified by saliva cotinine
1 secondary outcome
Number of Participants Abstinent From E-cigarette Use at Week 26
Time frame: Week 26
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 17 Dec 2025.
- Individual participant dataSharing planned: Yes. Data will be shared to an NIH data repository - the NIMH Data Archive
Related trials for E-cigarette Use
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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.
Michael Fatigate, PhD contact
Lisa Fucito, PhD principal investigator
Yale University
Benjamin Toll, PhD principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Varenicline 1mg BID in people with E-cigarette Use and Vaping, run by Yale University at 2 sites 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 2 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 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lisa Fucito, PhD (2032001470, lisa.fucito@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Abstinent From E-cigarette Use at Week 12 (time frame: 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 17 Dec 2025.