Trial Outcomes & Findings for A Trial of E-cigarettes in Current Cigarette Smokers (NCT NCT02357173)
NCT ID: NCT02357173
Last Updated: 2018-04-04
Results Overview
% of participants by group used e-cigarettes in week 16
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
study week 16
Results posted on
2018-04-04
Participant Flow
Participant milestones
| Measure |
16 mg Electronic Nicotine Delivery Systems (ENDS)
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
24 mg Electronic Nicotine Delivery Systems (ENDS)
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
Control Group
This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
21
|
22
|
|
Overall Study
COMPLETED
|
19
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of E-cigarettes in Current Cigarette Smokers
Baseline characteristics by cohort
| Measure |
16 mg Electronic Nicotine Delivery Systems (ENDS)
n=25 Participants
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
24 mg Electronic Nicotine Delivery Systems (ENDS)
n=21 Participants
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
Control Group
n=22 Participants
This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 14.4 • n=39 Participants
|
40.9 years
STANDARD_DEVIATION 12.3 • n=41 Participants
|
42.3 years
STANDARD_DEVIATION 14.2 • n=35 Participants
|
42.2 years
STANDARD_DEVIATION 13.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
41 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
27 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
14 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
37 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
10 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
30 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=39 Participants
|
21 participants
n=41 Participants
|
22 participants
n=35 Participants
|
68 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: study week 16% of participants by group used e-cigarettes in week 16
Outcome measures
| Measure |
24 mg Electronic Nicotine Delivery Systems (ENDS)
n=21 Participants
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
16 mg Electronic Nicotine Delivery Systems (ENDS)
n=25 Participants
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
Control Group
n=22 Participants
This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
|
|---|---|---|---|
|
Uptake of Electronic Nicotine Delivery Systems (ENDS)
|
57.14 percentage of participants
|
32 percentage of participants
|
13.64 percentage of participants
|
PRIMARY outcome
Timeframe: study enrollment to study week 16% of participants by group who purchased an ENDs product on their own during the study
Outcome measures
| Measure |
24 mg Electronic Nicotine Delivery Systems (ENDS)
n=21 Participants
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
16 mg Electronic Nicotine Delivery Systems (ENDS)
n=25 Participants
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
Control Group
n=22 Participants
This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
|
|---|---|---|---|
|
Independent Purchase of an ENDs Product
|
57 percentage of participants
|
28 percentage of participants
|
14 percentage of participants
|
PRIMARY outcome
Timeframe: study enrollment to study week 16% of participants who made any quit attempt during study
Outcome measures
| Measure |
24 mg Electronic Nicotine Delivery Systems (ENDS)
n=21 Participants
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
16 mg Electronic Nicotine Delivery Systems (ENDS)
n=25 Participants
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
Control Group
n=22 Participants
This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
|
|---|---|---|---|
|
% Quit Attempts
|
47.6 percentage of participants
|
40 percentage of participants
|
27.3 percentage of participants
|
PRIMARY outcome
Timeframe: week 16% of participants with CO-verified cigarette abstinence at study week 16
Outcome measures
| Measure |
24 mg Electronic Nicotine Delivery Systems (ENDS)
n=21 Participants
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
16 mg Electronic Nicotine Delivery Systems (ENDS)
n=25 Participants
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
Control Group
n=22 Participants
This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
|
|---|---|---|---|
|
Point Prevalence Abstinence
|
9.5 percentage of participants
|
4.0 percentage of participants
|
4.6 percentage of participants
|
Adverse Events
24 mg Electronic Nicotine Delivery Systems (ENDS)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
16 mg Electronic Nicotine Delivery Systems (ENDS)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
24 mg Electronic Nicotine Delivery Systems (ENDS)
n=21 participants at risk
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
16 mg Electronic Nicotine Delivery Systems (ENDS)
n=25 participants at risk
Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.
|
Control Group
n=22 participants at risk
This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
cough
|
23.8%
5/21 • Number of events 5 • study week 2 to study week 16
|
24.0%
6/25 • Number of events 7 • study week 2 to study week 16
|
18.2%
4/22 • Number of events 6 • study week 2 to study week 16
|
|
Gastrointestinal disorders
nausea
|
23.8%
5/21 • Number of events 6 • study week 2 to study week 16
|
12.0%
3/25 • Number of events 3 • study week 2 to study week 16
|
18.2%
4/22 • Number of events 4 • study week 2 to study week 16
|
|
Nervous system disorders
headache
|
14.3%
3/21 • Number of events 3 • study week 2 to study week 16
|
4.0%
1/25 • Number of events 1 • study week 2 to study week 16
|
18.2%
4/22 • Number of events 7 • study week 2 to study week 16
|
|
Gastrointestinal disorders
Mouth/throat irritation
|
14.3%
3/21 • Number of events 3 • study week 2 to study week 16
|
12.0%
3/25 • Number of events 3 • study week 2 to study week 16
|
22.7%
5/22 • Number of events 5 • study week 2 to study week 16
|
|
General disorders
Trouble sleeping
|
4.8%
1/21 • Number of events 1 • study week 2 to study week 16
|
4.0%
1/25 • Number of events 1 • study week 2 to study week 16
|
13.6%
3/22 • Number of events 4 • study week 2 to study week 16
|
|
Gastrointestinal disorders
heartburn
|
4.8%
1/21 • Number of events 1 • study week 2 to study week 16
|
0.00%
0/25 • study week 2 to study week 16
|
9.1%
2/22 • Number of events 2 • study week 2 to study week 16
|
|
Nervous system disorders
dizziness or lightheadness
|
0.00%
0/21 • study week 2 to study week 16
|
8.0%
2/25 • Number of events 2 • study week 2 to study week 16
|
4.5%
1/22 • Number of events 1 • study week 2 to study week 16
|
|
General disorders
other
|
9.5%
2/21 • Number of events 2 • study week 2 to study week 16
|
0.00%
0/25 • study week 2 to study week 16
|
0.00%
0/22 • study week 2 to study week 16
|
Additional Information
Dr. Matthew Carpenter
Medical University of South Carolina
Phone: 843-876-2436
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place