Trial Outcomes & Findings for Varenicline for Treatment of E-cigarette Dependence (NCT NCT05541497)
NCT ID: NCT05541497
Last Updated: 2024-12-02
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Week 8
Results posted on
2024-12-02
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
Completed 8 Weeks of Treatment
|
18
|
17
|
|
Overall Study
Completed 12 Week Follow up
|
18
|
15
|
|
Overall Study
COMPLETED
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Varenicline for Treatment of E-cigarette Dependence
Baseline characteristics by cohort
| Measure |
Varenicline + Self-Change Pamphlet
n=20 Participants
* 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
n=20 Participants
* 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
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
28.1 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
28.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
History of smoking
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Vaping Continuously All Day
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Years of E-cigarette Use
|
4.9 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
4.8 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
4.9 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
E-cigarette Dependence
|
13.4 score on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
15 score on a scale
STANDARD_DEVIATION 2.8 • n=7 Participants
|
14.2 score on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Type of E-cigarette Devices Used
Disposable
|
8 device
n=5 Participants
|
12 device
n=7 Participants
|
20 device
n=5 Participants
|
|
Type of E-cigarette Devices Used
Closed Pod/Cartridge
|
9 device
n=5 Participants
|
5 device
n=7 Participants
|
14 device
n=5 Participants
|
|
Type of E-cigarette Devices Used
Refillable Pod/Cartridge
|
1 device
n=5 Participants
|
3 device
n=7 Participants
|
4 device
n=5 Participants
|
|
Type of E-cigarette Devices Used
Refillable Tank
|
2 device
n=5 Participants
|
0 device
n=7 Participants
|
2 device
n=5 Participants
|
|
Nicotine Salt-Based E-Cigarette
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Comorbid Conditions
Any
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Comorbid Conditions
Depression
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Comorbid Conditions
Anxiety
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Comorbid Conditions
Other psychiatric
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Comorbid Conditions
Other substance use disorder
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Abstinence 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).
Outcome measures
| Measure |
Varenicline + Self-Change Pamphlet
n=20 Participants
* 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
n=20 Participants
* 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
|
|---|---|---|
|
Number of Participants Abstinent From Vaping at Week 8
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 12Abstinence 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).
Outcome measures
| Measure |
Varenicline + Self-Change Pamphlet
n=20 Participants
* 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
n=20 Participants
* 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
|
|---|---|---|
|
Number of Participants Abstinent From Vaping at Week 12
|
8 Participants
|
6 Participants
|
Adverse Events
Varenicline + Self-Change Pamphlet
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo + Self-Change Pamphlet
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Varenicline + Self-Change Pamphlet
n=20 participants at risk
* 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
n=20 participants at risk
* 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
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.0%
2/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
45.0%
9/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
General disorders
Fatigue
|
10.0%
2/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Psychiatric disorders
Depressed Mood
|
5.0%
1/20 • 12 weeks
|
10.0%
2/20 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Psychiatric disorders
Irritability
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Psychiatric disorders
Insomnia
|
20.0%
4/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • 12 weeks
|
5.0%
1/20 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Cardiac disorders
Chest Pain
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Gastrointestinal disorders
Belching
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • 12 weeks
|
0.00%
0/20 • 12 weeks
|
Additional Information
Lisa Fucito, PhD: Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry
Yale School of Medicine
Phone: (203) 688-1878
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place