Trial Outcomes & Findings for Effects of Nicotine Salt Aerosol on Cigarette Smokers (NCT NCT03974152)
NCT ID: NCT03974152
Last Updated: 2024-03-26
Results Overview
Change in plasma nicotine level
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Results posted on
2024-03-26
Participant Flow
This is a within-subjects design study with 3 conditions on 3 separate follow-ups after an initial screening visit. Enrolled participants were sometimes excluded from the study, primarily due to loss to follow-up.
Participant milestones
| Measure |
Own Brand Cigarette First, Then ENDS With Protonated Nicotine, Then ENDS With Unprotonated Nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
ENDS With Unprotonated Nicotine First, Then ENDS With Protonated Nicotine, Then Own Brand Cigarette
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
ENDS With Protonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Unprotonated Nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
ENDS With Protonated Nicotine First, Then ENDS With Unprotonated Nicotine, Then Own Brand Cigarette
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
Own Brand Cigarette First, Then ENDS With Unprotonated Nicotine, Then ENDS With Protonated Nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
ENDS With Unprotonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Protonated Nicotine
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
1
|
1
|
1
|
4
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Nicotine Salt Aerosol on Cigarette Smokers
Baseline characteristics by cohort
| Measure |
Own Brand Cigarette First, Then ENDS With Protonated Nicotine, Then ENDS With Unprotonated Nicotine
n=1 Participants
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
ENDS With Unprotonated Nicotine First, Then ENDS With Protonated Nicotine, Then Own Brand Cigarette
n=3 Participants
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
ENDS With Protonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Unprotonated Nicotine
n=1 Participants
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
ENDS With Protonated Nicotine First, Then ENDS With Unprotonated Nicotine, Then Own Brand Cigarette
n=1 Participants
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
Own Brand Cigarette First, Then ENDS With Unprotonated Nicotine, Then ENDS With Protonated Nicotine
n=1 Participants
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
ENDS With Unprotonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Protonated Nicotine
n=4 Participants
In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 0 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
38 years
STANDARD_DEVIATION 0 • n=5 Participants
|
30 years
STANDARD_DEVIATION 0 • n=4 Participants
|
41 years
STANDARD_DEVIATION 0 • n=21 Participants
|
40.8 years
STANDARD_DEVIATION 10.9 • n=10 Participants
|
34.3 years
STANDARD_DEVIATION 7.2 • n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
4 participants
n=10 Participants
|
11 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.Population: We were unable to collect this outcome measure (plasma nicotine) due to staffing issues and difficulties with blood draws.
Change in plasma nicotine level
Outcome measures
Outcome data not reported
Adverse Events
Own Brand Cigarette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ENDS: Subox Mini C With 18 mg Nicotine Salt (Protonated)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ENDS: Subox Mini C With 18 mg Nicotine Regular (Unprotonated)
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