Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2022-11-04
2023-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Varenicline + Self-Change Pamphlet
* 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.
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
Placebo + Self-Change Pamphlet
* 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.
Placebo
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
Interventions
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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
Placebo
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Lisa Fucito, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Benjamin Toll
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Yale University
New Haven, Connecticut, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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000
Identifier Type: OTHER
Identifier Source: secondary_id
2000032740
Identifier Type: -
Identifier Source: org_study_id