Smoking Cessation
Conditions
Keywords
e-cigarette
Brief 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. 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.
Interventions
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
DRUGPlacebo
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
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Abstinent From Vaping at Week 8 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Abstinent From Vaping at Week 12 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Placebo + Self-Change Pamphlet | Total | Varenicline + Self-Change Pamphlet |
|---|---|---|---|
| Age, Continuous | 28.1 years STANDARD_DEVIATION 6.4 | 28.2 years STANDARD_DEVIATION 8.5 | 28.4 years STANDARD_DEVIATION 10.3 |
| Comorbid Conditions Anxiety | 4 Participants | 10 Participants | 6 Participants |
| Comorbid Conditions Any | 7 Participants | 16 Participants | 9 Participants |
| Comorbid Conditions Depression | 3 Participants | 9 Participants | 6 Participants |
| Comorbid Conditions Other psychiatric | 1 Participants | 6 Participants | 5 Participants |
| Comorbid Conditions Other substance use disorder | 1 Participants | 1 Participants | 0 Participants |
| E-cigarette Dependence | 15 score on a scale STANDARD_DEVIATION 2.8 | 14.2 score on a scale STANDARD_DEVIATION 3.3 | 13.4 score on a scale STANDARD_DEVIATION 3.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 39 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of smoking | 11 Participants | 21 Participants | 10 Participants |
| Nicotine Salt-Based E-Cigarette | 19 Participants | 36 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 32 Participants | 17 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex/Gender, Customized Female | 10 Participants | 19 Participants | 9 Participants |
| Sex/Gender, Customized Male | 10 Participants | 20 Participants | 10 Participants |
| Sex/Gender, Customized Transgender | 0 Participants | 1 Participants | 1 Participants |
| Type of E-cigarette Devices Used Closed Pod/Cartridge | 5 device | 14 device | 9 device |
| Type of E-cigarette Devices Used Disposable | 12 device | 20 device | 8 device |
| Type of E-cigarette Devices Used Refillable Pod/Cartridge | 3 device | 4 device | 1 device |
| Type of E-cigarette Devices Used Refillable Tank | 0 device | 2 device | 2 device |
| Vaping Continuously All Day | 18 Participants | 33 Participants | 15 Participants |
| Years of E-cigarette Use | 4.8 years STANDARD_DEVIATION 1.8 | 4.9 years STANDARD_DEVIATION 2.4 | 4.9 years STANDARD_DEVIATION 2.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 12 / 20 | 5 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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).
Time frame: Week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Varenicline + Self-Change Pamphlet | Number of Participants Abstinent From Vaping at Week 8 | 9 Participants |
| Placebo + Self-Change Pamphlet | Number of Participants Abstinent From Vaping at Week 8 | 6 Participants |
95% CI: [0.68, 3.37]
Secondary
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).
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Varenicline + Self-Change Pamphlet | Number of Participants Abstinent From Vaping at Week 12 | 8 Participants |
| Placebo + Self-Change Pamphlet | Number of Participants Abstinent From Vaping at Week 12 | 6 Participants |
95% CI: [0.59, 3.13]