Trial Outcomes & Findings for Impact of E-cigarette Nicotine Concentration on Compensation (NCT NCT05887947)
NCT ID: NCT05887947
Last Updated: 2025-09-10
Results Overview
Differences within participants in total inhaled volume in electronic cigarette puff topography during the pharmacokinetic portions of lab visit 1 and 2
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
5 minutes
Results posted on
2025-09-10
Participant Flow
Participant milestones
| Measure |
5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette
Participants receive a 5% nicotine e-cigarette to use during the 1st vaping session. Following a minimum 48-hour washout period, participants receive a 1.8% nicotine e-cigarette to use during the 2nd vaping session.
|
1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette
Participants receive a 1.8% nicotine e-cigarette to use during the 1st vaping session. Following a minimum 48-hour washout period, participants receive a 5% nicotine e-cigarette to use during the 2nd vaping session.
|
Phase 2: 5% Nicotine E-cigarette
Participants randomized to switch to the 5% nicotine e-cigarette in the RCT portion of the study.
|
Phase 2: 1.8% Nicotine E-cigarette
Participants randomized to switch to the 1.8% nicotine e-cigarette in the RCT portion of the study.
|
|---|---|---|---|---|
|
First Intervention (1 Day)
STARTED
|
23
|
29
|
0
|
0
|
|
First Intervention (1 Day)
COMPLETED
|
23
|
29
|
0
|
0
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (48 Hours)
STARTED
|
23
|
29
|
0
|
0
|
|
Washout (48 Hours)
COMPLETED
|
23
|
25
|
0
|
0
|
|
Washout (48 Hours)
NOT COMPLETED
|
0
|
4
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
23
|
25
|
0
|
0
|
|
Second Intervention (1 Day)
COMPLETED
|
23
|
25
|
0
|
0
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
23
|
25
|
0
|
0
|
|
Washout (1 Week)
COMPLETED
|
22
|
23
|
0
|
0
|
|
Washout (1 Week)
NOT COMPLETED
|
1
|
2
|
0
|
0
|
|
Randomized Trial (6 Weeks; 5% vs. 1.8%)
STARTED
|
0
|
0
|
25
|
20
|
|
Randomized Trial (6 Weeks; 5% vs. 1.8%)
COMPLETED
|
0
|
0
|
24
|
19
|
|
Randomized Trial (6 Weeks; 5% vs. 1.8%)
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of E-cigarette Nicotine Concentration on Compensation
Baseline characteristics by cohort
| Measure |
5% Nicotine E-cigarette Followed by 1.8% Nicotine E-cigarette
n=23 Participants
At lab visit 1, participants receive a 5% nicotine e-cigarette to use during the vaping session. The researcher and participant were blinded to nicotine concentration during the visit. Following at least a 48-hour washout period, at lab visit 2, participant receive the 1.8% pod for the lab-based vaping session. The researcher and participant were blinded to nicotine concentration during the visit.
|
1.8% Nicotine E-cigarette Followed by 5% Nicotine E-cigarette
n=29 Participants
At lab visit 1, participants receive a 1.8% nicotine e-cigarette to use during the vaping session. The researcher and participant were blinded to nicotine concentration during the visit. Following at least a 48-hour washout period, at lab visit 2, participant receive the 5% pod for the lab-based vaping session. The researcher and participant were blinded to nicotine concentration during the visit.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 minutesPopulation: Data are reported for all participants that completed both lab visits. The number of participants analyzed differs from the number of participants who completed each period/treatment due to missingness of this specific outcome due to equipment malfunction. Data are missing at random and missingness is not systematic.
Differences within participants in total inhaled volume in electronic cigarette puff topography during the pharmacokinetic portions of lab visit 1 and 2
Outcome measures
| Measure |
5% Nicotine E-cigarette
n=39 Participants
Across two lab visits, participants received a 5% nicotine e-cigarette to use during the vaping session. The researcher and participant were blinded to nicotine concentration during the visit.
|
1.8% Nicotine E-cigarette
n=38 Participants
Across two lab visits, participants received a 1.8% nicotine e-cigarette to use during the vaping session. The researcher and participant were blinded to nicotine concentration during the visit.
|
|---|---|---|
|
Total Inhaled Volume
|
416.5 mL
Standard Deviation 258.3
|
490.3 mL
Standard Deviation 255.1
|
SECONDARY outcome
Timeframe: Week 6 of the Phase 2 period, approximately 8 weeks post-baselineSwitch trajectory: biochemically confirmed \[exhaled carbon monoxide\] complete switch, use of both e-cigarettes and cigarettes, use of only cigarettes, complete cessation \[non-use of e-cigarettes and cigarettes with biochemical confirmation\]
Outcome measures
| Measure |
5% Nicotine E-cigarette
n=24 Participants
Across two lab visits, participants received a 5% nicotine e-cigarette to use during the vaping session. The researcher and participant were blinded to nicotine concentration during the visit.
|
1.8% Nicotine E-cigarette
n=19 Participants
Across two lab visits, participants received a 1.8% nicotine e-cigarette to use during the vaping session. The researcher and participant were blinded to nicotine concentration during the visit.
|
|---|---|---|
|
Participant Switch Trajectory
complete switch
|
10 Participants
|
6 Participants
|
|
Participant Switch Trajectory
use of both e-cigarettes and cigarettes
|
10 Participants
|
13 Participants
|
|
Participant Switch Trajectory
use of only cigarettes
|
3 Participants
|
0 Participants
|
|
Participant Switch Trajectory
complete cessation
|
1 Participants
|
0 Participants
|
Adverse Events
5% Nicotine E-cigarette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1.8% Nicotine E-cigarette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place