Trial Outcomes & Findings for Comparative Abuse Liability Among African American and White Smokers (NCT NCT04646668)
NCT ID: NCT04646668
Last Updated: 2023-07-28
Results Overview
Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Baseline, after 10 puff bout of product at 5 minutes
Results posted on
2023-07-28
Participant Flow
Participant milestones
| Measure |
Cigarette, E-Cigarette Then Heat Not Burn.
At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 2, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 3, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session.
|
Cigarette, Heat Not Burn Then E-Cigarette
At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 2, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 3, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Abuse Liability Among African American and White Smokers
Baseline characteristics by cohort
| Measure |
Cigarette, E-Cigarette Then Heat Not Burn.
n=11 Participants
At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 2, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 3, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session.
|
Cigarette, Heat Not Burn Then E-Cigarette
n=11 Participants
At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 2, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session.
Following at least a 48-hour washout period, at lab visit 3, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
n=39 Participants
|
54.1 years
n=41 Participants
|
54.1 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=39 Participants
|
11 participants
n=41 Participants
|
22 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline, after 10 puff bout of product at 5 minutesPopulation: Blood plasma nicotine concentration 5 minutes after start
Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes
Outcome measures
| Measure |
Cigarette
n=21 Participants
Participants used their own brand cigarette during the first study visit.
|
E-Cigarette
n=21 Participants
Participants who used the e-cigarette product during either the second or third study visit.
|
Heat Not Burn
n=21 Participants
Participants who used the heat not burn product during either the second or third study visit.
|
|---|---|---|---|
|
Nicotine Delivery
|
14.13 ng/mL
Interval 4.3 to 35.6
|
6.79 ng/mL
Interval 0.5 to 26.6
|
9.15 ng/mL
Interval 1.5 to 22.5
|
Adverse Events
Cigarette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
E-Cigarette
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Heat Not Burn
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
Leah Lambart Graduate Research Assistant
University of Kansas Medical Center
Phone: 9139457862
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place