Trial Outcomes & Findings for Testing the Effect of ENDS Flavors on Neurotransmission (NCT NCT05836051)
NCT ID: NCT05836051
Last Updated: 2026-08-07
Results Overview
Absolute reinforcement will be calculated as the mean difference in puffs per day calculated as the average puffs per day during last four days minus the first four days of the 10-day use period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Pre to post-intervention (approximately 10 days)
Results posted on
2026-08-07
Participant Flow
Participant milestones
| Measure |
Hexyl Acetate
E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
Ethyl Acetate
E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Hexyl Acetate
E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
Ethyl Acetate
E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Testing the Effect of ENDS Flavors on Neurotransmission
Baseline characteristics by cohort
| Measure |
Hexyl Acetate
n=19 Participants
E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
Ethyl Acetate
n=17 Participants
E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 9.7 • n=20 Participants
|
42.9 years
STANDARD_DEVIATION 10.7 • n=20 Participants
|
38.4 years
STANDARD_DEVIATION 11.01 • n=40 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
36 Participants
n=40 Participants
|
|
Current Cigarette Use
|
7 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Current E-cigarette Use
|
16 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Pre to post-intervention (approximately 10 days)Population: This analysis was conducted on a subsample of 25 out of 36 participants that completed a functional magnetic resonance imaging scan at baseline and post-use follow-up laboratory visits.
Brain reward reactivity will be calculated as the difference in the percent of BOLD signal calculated by subtracting the absolute percentage at the post-scan from baseline in a pre-defined ventral tegmental area (VTA) region of interest during electronic nicotine delivery system (ENDS) inhalation.
Outcome measures
| Measure |
Hexyl Acetate
n=13 Participants
E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
Ethyl Acetate
n=12 Participants
E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
|---|---|---|
|
Brain Reward Reactivity
|
-5.54 percentage of BOLD signal change
Standard Deviation 25.58
|
-3.42 percentage of BOLD signal change
Standard Deviation 15.82
|
PRIMARY outcome
Timeframe: Pre to post-intervention (approximately 10 days)Population: 35 participants completed the baseline and post-use laboratory visits with daily logs of E-cigarette puffs collected between visits.
Absolute reinforcement will be calculated as the mean difference in puffs per day calculated as the average puffs per day during last four days minus the first four days of the 10-day use period.
Outcome measures
| Measure |
Hexyl Acetate
n=19 Participants
E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
Ethyl Acetate
n=16 Participants
E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
|---|---|---|
|
Absolute Reinforcement
|
13.85 puffs per day
Standard Deviation 11.19
|
-2.37 puffs per day
Standard Deviation 7.92
|
Adverse Events
Hexyl Acetate
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ethyl Acetate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hexyl Acetate
n=19 participants at risk
E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
Ethyl Acetate
n=17 participants at risk
E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Flavor: E-liquid flavor chemicals
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
0.00%
0/19 • Baseline to post-use was approximately 12 days.
|
5.9%
1/17 • Number of events 1 • Baseline to post-use was approximately 12 days.
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Number of events 1 • Baseline to post-use was approximately 12 days.
|
0.00%
0/17 • Baseline to post-use was approximately 12 days.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/19 • Baseline to post-use was approximately 12 days.
|
5.9%
1/17 • Number of events 1 • Baseline to post-use was approximately 12 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place