Smoking CessationPhase 2NCT05541497
Varenicline for Treatment of E-cigarette Dependence
A Phase 2 study testing Varenicline Tartrate in people with Smoking Cessation, run by Yale University at 2 sites in United States.
Trial summary
Varenicline is used to treat tobacco use dependence. It helps reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products. Varenicline has been proven to reduce the desire to smoke cigarettes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Varenicline Tartrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2022to 1 Sep 2023
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- daily use of an e-cigarette containing nicotine (defined as use for at least 25 days out of the past month)
- use of an e-cigarette containing nicotine> 6 months
- have desire to quit e-cigarettes, are willing to set a quit date and maintain e-cigarette abstinence
- have daily access to a smartphone or have regular (daily) access/use of email
- live in South Carolina or Connecticut
Who cannot join
- Vulnerable Populations: Not be enrolling vulnerable populations, specifically pregnant women, children, prisoners, or institutionalized individuals
- The investigators will not enroll participants incapable of providing their own consent. The rationale will be provided to the individual as well as his or her family members.
- Referrals for further evaluation, including urgent or emergent evaluation, will be made as needed and clinically warranted.
- exclude individuals with medical contraindications for varenicline use (i.e., severe renal impairment)
- exclude anyone currently using smoking cessation medications.
- Individuals will also be excluded if another household member is currently enrolled in the study.
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- Individuals will be excluded if not proficient in English.
- Individuals will be excluded if they have smoked any combustible cigarettes in the past 6 months.
- Verification of Non-Pregnancy: Females ages <55 will be mailed a commercially available pregnancy test to verify non-pregnancy. Written confirmation of negative pregnancy test via REDCap will be required prior to enrollment in the trial. Participants are also informed that they should let us know if they become pregnant during the trial. Medications will not be sent until this verification is in place. These procedures are based on the Medical University of South Carolina Internal Review Board approved STARS protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Yale University
New Haven, Connecticut, 06520
About this study
Varenicline is used to treat tobacco use dependence. It helps reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products. Varenicline has been proven to reduce the desire to smoke cigarettes. This study aims to test whether it shows a similar benefit for individuals who vape and are interested in quitting.
Read the detailed description
Varenicline is a highly efficacious FDA-approved smoking cessation pharmacotherapy. The aim of this study is to examine the effectiveness of varenicline for e-cigarette cessation medication for mono- e-cigarette use in combination with a minimal, self-guided behavior change booklet. This booklet will include general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up phase. Participants will be randomized to receive an 8-week supply of varenicline or matching placebo (gel capsule filled with cellulose powder) in combination with the self-change booklet. The investigators hypothesize that participants who receive varenicline will have higher rates of e-cigarette cessation.
- Conditions
- Smoking Cessation
- Being tested
- Varenicline Tartrate, Placebo
- Keywords
- e-cigarette
- Medical subject headings
- Smoking Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline TartrateDrug
Days 1-3: 0.5mg study pill once per day, Days 4-7: 0.5mg study pill twice per day, Weeks 2-8: 1mg study pill twice per day
PlaceboDrug
Days 1-3: 0.5mg pill once per day, Days 4-7: 0.5mg pill twice per day, Weeks 2-8: 1mg pill twice per day
| Study group | Role | What they receive |
|---|---|---|
| Varenicline + Self-Change Pamphlet | Experimental | * Days 1-3: 0.5mg study pill once per day
* Days 4-7: 0.5mg study pill twice per day
* Weeks 2-8: 1mg study pill twice per day in combination with a minimal, self-guided behavior change booklet. This booklet includes general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up. Receives: Drug: Varenicline Tartrate |
| Placebo + Self-Change Pamphlet | Placebo comparator | * Days 1-3: 0.5mg placebo pill once per day
* Days 4-7: 0.5mg placebo pill twice per day
* Weeks 2-8: 1mg placebo pill twice per day in combination with a minimal, self-guided behavior change booklet. This booklet includes general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up. 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 Vaping at Week 8
Abstinence is defined as no vaping, not even a puff, every day for the last 7 days via self-report (i.e., 7 day point prevalent abstinence).
Measured: Week 8
Secondary outcomes (1)
Number of Participants Abstinent From Vaping at Week 12
Abstinence is defined as no vaping, not even a puff, every day for the last 7 days via self-report (i.e., 7 day point prevalent abstinence).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start4 Nov 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Fucito, Ph.D., Principal investigator, Yale UniversityBenjamin Toll, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541497
- Sponsor's protocol ID
- 2000032740
- Other IDs
- 000
- Status last verified
- Nov 2024
- First submitted
- 12 Sep 2022
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline for Treatment of E-cigarette Dependence
- ClinicalTrials.gov ID
- NCT05541497
- Acronym / sponsor ID
- 2000032740
- Conditions
- Smoking Cessation
- Keywords
- e-cigarette
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Posted 2 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Varenicline is used to treat tobacco use dependence. It helps reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products. Varenicline has been proven to reduce the desire to smoke cigarettes. This study aims to test whether it shows a similar benefit for individuals who vape and are interested in quitting.
Detailed description
Varenicline is a highly efficacious FDA-approved smoking cessation pharmacotherapy. The aim of this study is to examine the effectiveness of varenicline for e-cigarette cessation medication for mono- e-cigarette use in combination with a minimal, self-guided behavior change booklet. This booklet will include general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up phase. Participants will be randomized to receive an 8-week supply of varenicline or matching placebo (gel capsule filled with cellulose powder) in combination with the self-change booklet. The investigators hypothesize that participants who receive varenicline will have higher rates of e-cigarette cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline + Self-Change Pamphlet | Experimental | Drug: Varenicline Tartrate* Days 1-3: 0.5mg study pill once per day * Days 4-7: 0.5mg study pill twice per day * Weeks 2-8: 1mg study pill twice per day in combination with a minimal, self-guided behavior change booklet. This booklet includes general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up. |
| Placebo + Self-Change Pamphlet | Placebo comparator | Drug: Placebo* Days 1-3: 0.5mg placebo pill once per day * Days 4-7: 0.5mg placebo pill twice per day * Weeks 2-8: 1mg placebo pill twice per day in combination with a minimal, self-guided behavior change booklet. This booklet includes general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- daily use of an e-cigarette containing nicotine (defined as use for at least 25 days out of the past month)
- use of an e-cigarette containing nicotine> 6 months
- have desire to quit e-cigarettes, are willing to set a quit date and maintain e-cigarette abstinence
- have daily access to a smartphone or have regular (daily) access/use of email
- live in South Carolina or Connecticut
Key exclusion criteria (9 listed)
- Vulnerable Populations: Not be enrolling vulnerable populations, specifically pregnant women, children, prisoners, or institutionalized individuals
- The investigators will not enroll participants incapable of providing their own consent. The rationale will be provided to the individual as well as his or her family members.
- Referrals for further evaluation, including urgent or emergent evaluation, will be made as needed and clinically warranted.
- exclude individuals with medical contraindications for varenicline use (i.e., severe renal impairment)
- exclude anyone currently using smoking cessation medications.
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 TartrateDays 1-3: 0.5mg study pill once per day, Days 4-7: 0.5mg study pill twice per day, Weeks 2-8: 1mg study pill twice per day | Drug | Varenicline + Self-Change Pamphlet |
| PlaceboDays 1-3: 0.5mg pill once per day, Days 4-7: 0.5mg pill twice per day, Weeks 2-8: 1mg pill twice per day | Drug | Placebo + Self-Change Pamphlet |
Primary outcome
Number of Participants Abstinent From Vaping at Week 8
Time frame: Week 8
Abstinence is defined as no vaping, not even a puff, every day for the last 7 days via self-report (i.e., 7 day point prevalent abstinence).
1 secondary outcome
Number of Participants Abstinent From Vaping at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lisa Fucito, Ph.D. principal investigator
Yale University
Benjamin Toll 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 Tartrate in people with Smoking Cessation, 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 5 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 2 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2024). 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?
Number of Participants Abstinent From Vaping at Week 8 (time frame: Week 8). 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 2 Dec 2024.