Trial Outcomes & Findings for Quit or Switch: E-cigarette Study (NCT NCT05525078)
NCT ID: NCT05525078
Last Updated: 2024-04-26
Results Overview
daily use of e-cigarette or NRT instead of cigarettes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
day 0 through day 35
Results posted on
2024-04-26
Participant Flow
Participant milestones
| Measure |
Switch Group
Participants in the Switch group will receive a 5-week supply of e-cigarettes.
e-cigarette: Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product.
|
Meds Group
Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge).
Nicotine patch, Nicotine lozenge: Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quit or Switch: E-cigarette Study
Baseline characteristics by cohort
| Measure |
Switch Group
n=20 Participants
Participants in the Switch group will receive a 5-week supply of e-cigarettes.
e-cigarette: Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product.
|
Meds Group
n=10 Participants
Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge).
Nicotine patch, Nicotine lozenge: Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
49.6 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
50.4 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: day 0 through day 35daily use of e-cigarette or NRT instead of cigarettes
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 4Self reported point prevalence abstinence from cigarettes and expired carbon monoxide \< 6 ppm
Outcome measures
| Measure |
Switch Group
n=20 Participants
Participants in the Switch group will receive a 5-week supply of e-cigarettes.
e-cigarette: Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product.
|
Meds Group
n=10 Participants
Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge).
Nicotine patch, Nicotine lozenge: Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided.
|
|---|---|---|
|
Percentage of Participants Who Have Biochemically-confirmed Abstinence From Cigarette Smoking at Week 4
|
7 Participants
|
1 Participants
|
Adverse Events
Switch Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Meds Group
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Switch Group
n=20 participants at risk
Participants in the Switch group will receive a 5-week supply of e-cigarettes.
e-cigarette: Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product.
|
Meds Group
n=10 participants at risk
Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge).
Nicotine patch, Nicotine lozenge: Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Thoughts
|
0.00%
0/20 • 5 weeks
|
10.0%
1/10 • Number of events 1 • 5 weeks
|
Other adverse events
| Measure |
Switch Group
n=20 participants at risk
Participants in the Switch group will receive a 5-week supply of e-cigarettes.
e-cigarette: Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product.
|
Meds Group
n=10 participants at risk
Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge).
Nicotine patch, Nicotine lozenge: Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Burning, mucus, or irritation in the throat/sinuses
|
5.0%
1/20 • Number of events 1 • 5 weeks
|
20.0%
2/10 • Number of events 2 • 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Changes in taste/dry mouth
|
10.0%
2/20 • Number of events 2 • 5 weeks
|
10.0%
1/10 • Number of events 1 • 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dry Cough
|
15.0%
3/20 • Number of events 3 • 5 weeks
|
20.0%
2/10 • Number of events 2 • 5 weeks
|
|
Nervous system disorders
Insomnia or dream abnormalities
|
0.00%
0/20 • 5 weeks
|
40.0%
4/10 • Number of events 4 • 5 weeks
|
|
Gastrointestinal disorders
Nausea, flatulence, or stomachache
|
0.00%
0/20 • 5 weeks
|
10.0%
1/10 • Number of events 2 • 5 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/20 • 5 weeks
|
20.0%
2/10 • Number of events 2 • 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat or mouth irritation/ulcers
|
5.0%
1/20 • Number of events 1 • 5 weeks
|
10.0%
1/10 • Number of events 1 • 5 weeks
|
|
Ear and labyrinth disorders
Vertigo or Dizziness
|
10.0%
2/20 • Number of events 2 • 5 weeks
|
0.00%
0/10 • 5 weeks
|
|
Cardiac disorders
headaches
|
5.0%
1/20 • Number of events 1 • 5 weeks
|
40.0%
4/10 • Number of events 4 • 5 weeks
|
|
Gastrointestinal disorders
heartburn
|
0.00%
0/20 • 5 weeks
|
10.0%
1/10 • Number of events 1 • 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
short of breath
|
0.00%
0/20 • 5 weeks
|
10.0%
1/10 • Number of events 1 • 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
brochitis
|
0.00%
0/20 • 5 weeks
|
10.0%
1/10 • Number of events 1 • 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
increased mucus / phlegm
|
5.0%
1/20 • Number of events 1 • 5 weeks
|
0.00%
0/10 • 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/20 • 5 weeks
|
10.0%
1/10 • Number of events 1 • 5 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place