Trial Outcomes & Findings for Effects of Menthol in E-cigarettes on Smoking Behaviors (NCT NCT04521647)
NCT ID: NCT04521647
Last Updated: 2026-06-16
Results Overview
Mean plasma levels obtained after e-cigarette administration at each lab session (lab 1 and lab 2).
COMPLETED
PHASE1
14 participants
Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure.
2026-06-16
Participant Flow
All participants will be exposed to the two flavor conditions (tobacco and menthol) in a counterbalanced randomized order. Each lab session exposure will consist of 10 3-sec puffs separated by 30 second intervals and will be separated by a minimum of 24 hours and maximum of 2 weeks.
Participant milestones
| Measure |
Menthol Flavor First, Then Tobacco Flavor
Participants were exposed to Menthol then Tobacco flavor with a 60 second washout in between.
|
Tobacco Flavor First, Then Menthol Flavor
Participants were exposed to Tobacco then Menthol flavor with a 60 second washout in between.
|
|---|---|---|
|
First Lab Session
STARTED
|
7
|
7
|
|
First Lab Session
COMPLETED
|
5
|
5
|
|
First Lab Session
NOT COMPLETED
|
2
|
2
|
|
Between Sessions (2 Days up to 2 Weeks)
STARTED
|
5
|
5
|
|
Between Sessions (2 Days up to 2 Weeks)
COMPLETED
|
5
|
5
|
|
Between Sessions (2 Days up to 2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Lab Session 2
STARTED
|
5
|
5
|
|
Lab Session 2
COMPLETED
|
5
|
5
|
|
Lab Session 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Menthol Flavor First, Then Tobacco Flavor
Participants were exposed to Menthol then Tobacco flavor with a 60 second washout in between.
|
Tobacco Flavor First, Then Menthol Flavor
Participants were exposed to Tobacco then Menthol flavor with a 60 second washout in between.
|
|---|---|---|
|
First Lab Session
Adverse Event
|
2
|
0
|
|
First Lab Session
Complications with blood draw
|
0
|
1
|
|
First Lab Session
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Effects of Menthol in E-cigarettes on Smoking Behaviors
Baseline characteristics by cohort
| Measure |
Menthol / Nicotine
n=14 Participants
All participants complete both arms described in the protocol section (menthol arm and tobacco arm).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
40.36 years
STANDARD_DEVIATION 9.56 • n=20 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure.Population: Outcomes from 8 participants. 10 participants completed both menthol flavor and tobacco flavor labs (5 in each arm), however the lab/blood analysis was not valid for 2 participants (one in each arm).
Mean plasma levels obtained after e-cigarette administration at each lab session (lab 1 and lab 2).
Outcome measures
| Measure |
Menthol Nicotine Flavor
n=8 Participants
Participants will receive 5% nicotine with menthol flavor in an e-cigarette
Each exposure will be 10 3-sec puffs
|
Tobacco Nicotine Flavor
n=8 Participants
Participants will receive 5% nicotine with tobacco flavor in an e-cigarette
Each exposure will be 10 3-sec puffs
|
|---|---|---|
|
Plasma Nicotine Levels
|
3.1165000 ng/mL
Standard Deviation 2.5275116
|
2.8126250 ng/mL
Standard Deviation 2.8678062
|
PRIMARY outcome
Timeframe: Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure.Population: Outcomes from 8 participants; 4 in each arm. 10 participants completed both menthol flavor and tobacco flavor labs, however the lab/blood analysis was not valid for 2 participants.
Mean Area under the curve (AUC) for plasma nicotine and NMR were computed and then log transformed to reduce skewness of the two measures.
Outcome measures
| Measure |
Menthol Nicotine Flavor
n=8 Participants
Participants will receive 5% nicotine with menthol flavor in an e-cigarette
Each exposure will be 10 3-sec puffs
|
Tobacco Nicotine Flavor
n=8 Participants
Participants will receive 5% nicotine with tobacco flavor in an e-cigarette
Each exposure will be 10 3-sec puffs
|
|---|---|---|
|
Nicotine Metabolic Rate
|
5.15 ng/mL*minutes
Standard Deviation 0.56
|
5.05 ng/mL*minutes
Standard Deviation 0.62
|
Adverse Events
Menthol Flavor
Tobacco Flavor
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Menthol Flavor
n=14 participants at risk
Participants receiving menthol flavor
|
Tobacco Flavor
n=14 participants at risk
Participants receiving tobacco flavor
|
|---|---|---|
|
Cardiac disorders
High Blood Pressure
|
7.1%
1/14 • Number of events 1 • Participant's Adverse Event data was collected from study enrollment through both lab sessions (menthol and nicotine); approximately 3 weeks.
|
0.00%
0/14 • Participant's Adverse Event data was collected from study enrollment through both lab sessions (menthol and nicotine); approximately 3 weeks.
|
|
Nervous system disorders
Lightheaded
|
7.1%
1/14 • Number of events 1 • Participant's Adverse Event data was collected from study enrollment through both lab sessions (menthol and nicotine); approximately 3 weeks.
|
0.00%
0/14 • Participant's Adverse Event data was collected from study enrollment through both lab sessions (menthol and nicotine); approximately 3 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place