Trial Outcomes & Findings for Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns (NCT NCT03844672)
NCT ID: NCT03844672
Last Updated: 2024-10-24
Results Overview
Participants complete weekly surveys reporting the number of cigarettes smoked each day on a continuous scale
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
Week 3
Results posted on
2024-10-24
Participant Flow
Participant milestones
| Measure |
Low Concentration / Low Power
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
Low Concentration / High Power
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
High Concentration / Low Power
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
High Concentration / High Power
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
23
|
23
|
|
Overall Study
COMPLETED
|
17
|
18
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns
Baseline characteristics by cohort
| Measure |
Low Concentration / Low Power
n=23 Participants
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
Low Concentration / High Power
n=24 Participants
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
High Concentration / Low Power
n=23 Participants
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
High Concentration / High Power
n=23 Participants
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 12.0 • n=99 Participants
|
48.9 years
STANDARD_DEVIATION 13.3 • n=107 Participants
|
51.3 years
STANDARD_DEVIATION 13.1 • n=206 Participants
|
49.7 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 12.3 • n=31 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
77 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 3Participants complete weekly surveys reporting the number of cigarettes smoked each day on a continuous scale
Outcome measures
| Measure |
Low Concentration / Low Power
n=18 Participants
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
Low Concentration / High Power
n=21 Participants
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
High Concentration / Low Power
n=17 Participants
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
High Concentration / High Power
n=17 Participants
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
|---|---|---|---|---|
|
Mean Cigarettes Per Day
|
13.1 cigarettes per day
Standard Deviation 9.3
|
12.6 cigarettes per day
Standard Deviation 6.0
|
12.2 cigarettes per day
Standard Deviation 8.8
|
13.3 cigarettes per day
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Week 3Participants complete weekly surveys reporting the number of e-cigarette puffing episodes each day on a continuous scale
Outcome measures
| Measure |
Low Concentration / Low Power
n=18 Participants
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
Low Concentration / High Power
n=21 Participants
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
High Concentration / Low Power
n=17 Participants
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
High Concentration / High Power
n=17 Participants
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
|---|---|---|---|---|
|
Average Number of E-cigarette Puffing Episodes
|
4.8 cigarettes per day
Standard Deviation 5.4
|
6.5 cigarettes per day
Standard Deviation 10.7
|
5.4 cigarettes per day
Standard Deviation 4.5
|
3.0 cigarettes per day
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Week 3Participants complete lab-based choice task at Week 3 visit in which they choose between smoking conventional cigarette and e-cigarette over 10 trials. Outcome is number of times each participant chooses to smoke conventional cigarette.
Outcome measures
| Measure |
Low Concentration / Low Power
n=18 Participants
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
Low Concentration / High Power
n=21 Participants
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
High Concentration / Low Power
n=17 Participants
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
High Concentration / High Power
n=17 Participants
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
|---|---|---|---|---|
|
Number of Choices to Smoke Cigarette in Lab Setting
|
1.7 Events
Standard Error 0.42
|
2.4 Events
Standard Error 0.38
|
1.8 Events
Standard Error 0.44
|
2.4 Events
Standard Error 0.43
|
Adverse Events
Low Concentration / Low Power
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Low Concentration / High Power
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
High Concentration / Low Power
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
High Concentration / High Power
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Concentration / Low Power
n=23 participants at risk
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
Low Concentration / High Power
n=24 participants at risk
Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks
|
High Concentration / Low Power
n=23 participants at risk
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
High Concentration / High Power
n=23 participants at risk
Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2 • Two months
|
20.8%
5/24 • Number of events 5 • Two months
|
17.4%
4/23 • Number of events 4 • Two months
|
13.0%
3/23 • Number of events 3 • Two months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
3/23 • Number of events 3 • Two months
|
16.7%
4/24 • Number of events 6 • Two months
|
13.0%
3/23 • Number of events 3 • Two months
|
4.3%
1/23 • Number of events 1 • Two months
|
|
Respiratory, thoracic and mediastinal disorders
Increased Phlegm
|
8.7%
2/23 • Number of events 2 • Two months
|
4.2%
1/24 • Number of events 1 • Two months
|
13.0%
3/23 • Number of events 3 • Two months
|
8.7%
2/23 • Number of events 3 • Two months
|
|
Gastrointestinal disorders
Throat and Mouth Irritation
|
13.0%
3/23 • Number of events 3 • Two months
|
8.3%
2/24 • Number of events 2 • Two months
|
0.00%
0/23 • Two months
|
8.7%
2/23 • Number of events 2 • Two months
|
|
Gastrointestinal disorders
Burning in the Throat
|
8.7%
2/23 • Number of events 2 • Two months
|
16.7%
4/24 • Number of events 4 • Two months
|
8.7%
2/23 • Number of events 2 • Two months
|
8.7%
2/23 • Number of events 2 • Two months
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • Two months
|
8.3%
2/24 • Number of events 2 • Two months
|
4.3%
1/23 • Number of events 1 • Two months
|
4.3%
1/23 • Number of events 2 • Two months
|
|
Nervous system disorders
Dizziness
|
13.0%
3/23 • Number of events 3 • Two months
|
4.2%
1/24 • Number of events 1 • Two months
|
4.3%
1/23 • Number of events 1 • Two months
|
0.00%
0/23 • Two months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Problems
|
0.00%
0/23 • Two months
|
8.3%
2/24 • Number of events 2 • Two months
|
0.00%
0/23 • Two months
|
0.00%
0/23 • Two months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place