Trial Outcomes & Findings for Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth (NCT NCT05458895)

Results Overview

Plasma nicotine concentration from blood drawn (3mL) 4 times in each session at baseline (0 min), 5 min., 10 min., 35 min.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

88 participants

Primary outcome timeframe

0, 5, 10, 35 min.

Results posted on

2024-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Overall Population Full population of participants evaluated at baseline
Overall Study STARTED	88
Overall Study Usual Brand e-Cigarette	87
Overall Study Low Concentration Free-base Nicotine (1%), Menthol Flavor	65
Overall Study Low Concentration Free-base Nicotine (1%), Tobacco Flavor	64
Overall Study Low Concentration Nicotine Salt (1%), Menthol Flavor	61
Overall Study Low Concentration Nicotine Salt (1%), Tobacco Flavor	64
Overall Study High Concentration Free-base Nicotine (1%), Menthol Flavor	64
Overall Study High Concentration Free-base Nicotine (1%), Tobacco Flavor	63
Overall Study High Concentration Nicotine Salt (1%), Menthol Flavor	60
Overall Study High Concentration Nicotine Salt (1%), Tobacco Flavor	65
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Population Full population of participants evaluated at baseline
Overall Study Withdrawal by Subject	8
Overall Study Lost to Follow-up	17
Overall Study Pregnancy	2
Overall Study Withdrawal by Study Team	1

Baseline Characteristics

Two participants failed to provide the age at which they began regularly using e-cigarettes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Population n=87 Participants Full population of participants evaluated at baseline
Age, Continuous	22.36 years STANDARD_DEVIATION 1.35 • n=87 Participants
Sex: Female, Male Female	51 Participants n=87 Participants
Sex: Female, Male Male	36 Participants n=87 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=87 Participants
Race (NIH/OMB) Asian	8 Participants n=87 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=87 Participants
Race (NIH/OMB) Black or African American	4 Participants n=87 Participants
Race (NIH/OMB) White	73 Participants n=87 Participants
Race (NIH/OMB) More than one race	1 Participants n=87 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=87 Participants
Years of regular e-cigarette use	3.29 years STANDARD_DEVIATION 2.13 • n=85 Participants • Two participants failed to provide the age at which they began regularly using e-cigarettes

PRIMARY outcome

Timeframe: 0, 5, 10, 35 min.

Population: Number analyzed is slightly different at each of the time points due to missing blood draws

Plasma nicotine concentration from blood drawn (3mL) 4 times in each session at baseline (0 min), 5 min., 10 min., 35 min.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=63 Participants Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n=60 Participants Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor n=60 Participants Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor n=63 Participants Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor n=62 Participants Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor n=62 Participants Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor n=59 Participants Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor n=62 Participants Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand n=83 Participants Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Plasma Nicotine Concentration Baseline	0.78 ng/ml Interval 0.32 to 1.65	1.08 ng/ml Interval 0.45 to 2.34	0.89 ng/ml Interval 0.35 to 1.89	1.16 ng/ml Interval 0.49 to 2.62	0.80 ng/ml Interval 0.3 to 1.92	0.88 ng/ml Interval 0.38 to 2.1	1.03 ng/ml Interval 0.48 to 2.36	1.01 ng/ml Interval 0.51 to 2.21	0.43 ng/ml Interval 0.19 to 0.83
Plasma Nicotine Concentration 35 Minutes	4.46 ng/ml Interval 2.45 to 8.35	3.51 ng/ml Interval 2.07 to 7.44	5.97 ng/ml Interval 2.91 to 10.7	5.28 ng/ml Interval 2.98 to 11.45	6.39 ng/ml Interval 3.59 to 13.95	4.23 ng/ml Interval 2.19 to 10.7	12.90 ng/ml Interval 6.0 to 27.3	10.60 ng/ml Interval 4.47 to 21.6	20.40 ng/ml Interval 10.25 to 31.6
Plasma Nicotine Concentration 5 Minutes	3.04 ng/ml Interval 1.59 to 5.16	2.63 ng/ml Interval 1.32 to 4.73	4.47 ng/ml Interval 2.3 to 7.61	4.66 ng/ml Interval 2.61 to 8.1	3.63 ng/ml Interval 1.72 to 6.15	3.29 ng/ml Interval 1.68 to 5.8	7.83 ng/ml Interval 4.33 to 16.9	8.76 ng/ml Interval 4.13 to 14.9	12.50 ng/ml Interval 7.49 to 19.3
Plasma Nicotine Concentration 10 Minutes	3.12 ng/ml Interval 2.02 to 5.76	3.18 ng/ml Interval 1.75 to 5.17	4.92 ng/ml Interval 2.35 to 7.07	4.66 ng/ml Interval 2.67 to 7.27	4.45 ng/ml Interval 2.46 to 7.9	4.14 ng/ml Interval 1.81 to 7.18	8.10 ng/ml Interval 4.97 to 19.1	7.02 ng/ml Interval 4.29 to 16.6	14.10 ng/ml Interval 8.11 to 21.0

PRIMARY outcome

Timeframe: 30 minutes

E-cig puff topography data collection for abuse liability. Number of puffs taken during the 30 minutes of ad libitum (as desired) vaping session.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=65 Participants Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor n=61 Participants Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor n=64 Participants Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor n=63 Participants Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor n=60 Participants Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor n=65 Participants Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand n=87 Participants Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Puff Count	16.17 Number of Puffs Standard Deviation 12.04	16.67 Number of Puffs Standard Deviation 13.84	17.67 Number of Puffs Standard Deviation 13.54	17.88 Number of Puffs Standard Deviation 13.90	12.52 Number of Puffs Standard Deviation 12.13	11.29 Number of Puffs Standard Deviation 12.64	14.50 Number of Puffs Standard Deviation 11.80	13.97 Number of Puffs Standard Deviation 12.07	12.40 Number of Puffs Standard Deviation 10.69

PRIMARY outcome

Timeframe: 30 minutes

Population: Participants who attended the study visit and whose puff duration was able to be recorded.

E-cig puff topography data collection for abuse liability. Average puff duration during the 30 minutes of ad libitum (as desired) vaping session, in seconds.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=1051 Puffs Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n=1067 Puffs Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor n=1078 Puffs Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor n=1144 Puffs Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor n=801 Puffs Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor n=711 Puffs Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor n=870 Puffs Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor n=908 Puffs Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand n=1079 Puffs Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Average Puff Duration	3.20 seconds Standard Deviation 1.04	3.04 seconds Standard Deviation 1.08	3.16 seconds Standard Deviation 1.07	3.15 seconds Standard Deviation 1.10	2.65 seconds Standard Deviation 0.92	2.57 seconds Standard Deviation 0.97	2.77 seconds Standard Deviation 1.03	2.75 seconds Standard Deviation 1.08	2.70 seconds Standard Deviation 1.15

PRIMARY outcome

Timeframe: 30 minutes

Population: Participants who attended the study visit and whose puff volume was able to be recorded.

E-cig puff topography data collection for abuse liability. The total volume of all puffs taken for each participant during the 30 minutes of ad libitum (as desired) vaping session, in ml.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=1051 Puffs Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n=1067 Puffs Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor n=1078 Puffs Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor n=1144 Puffs Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor n=53 Participants Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor n=54 Participants Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor n=57 Participants Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor n=58 Participants Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand n=82 Participants Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Average Puff Volume	48.68 ml Standard Deviation 17.28	46.31 ml Standard Deviation 18.44	50.64 ml Standard Deviation 22.05	51.92 ml Standard Deviation 30.01	36.82 ml Standard Deviation 12.13	35.12 ml Standard Deviation 13.16	41.76 ml Standard Deviation 15.35	40.86 ml Standard Deviation 17.26	69.29 ml Standard Deviation 40.42

PRIMARY outcome

Timeframe: Baseline and 35 minutes

Lung function data will be collect using a handheld spirometry device. Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Measures amount inhaled and how quickly exhaled. Change from baseline in forced expiratory volume (FEV) Change from baseline in forced vital capacity (FVC)

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=65 Participants Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor n=61 Participants Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor n=64 Participants Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor n=63 Participants Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor n=60 Participants Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor n=65 Participants Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand n=87 Participants Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Lung Function Assessment FVC	-0.02 Liters Standard Deviation 0.29	-0.01 Liters Standard Deviation 0.25	-0.0006 Liters Standard Deviation 0.24	0.30 Liters Standard Deviation 2.36	-0.12 Liters Standard Deviation 0.53	-0.02 Liters Standard Deviation 0.53	-0.01 Liters Standard Deviation 0.37	-0.23 Liters Standard Deviation 1.68	0.13 Liters Standard Deviation 0.42
Lung Function Assessment FEV	-0.03 Liters Standard Deviation 0.21	-0.05 Liters Standard Deviation 0.21	-0.01 Liters Standard Deviation 0.19	0.003 Liters Standard Deviation 0.24	-0.08 Liters Standard Deviation 0.40	-0.02 Liters Standard Deviation 0.38	-0.05 Liters Standard Deviation 0.24	-0.04 Liters Standard Deviation 0.24	0.09 Liters Standard Deviation 0.39

PRIMARY outcome

Timeframe: 35 minutes

Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Airway inflammation will be assessed using exhaled nitric oxide via the NIOX VERO.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=65 Participants Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor n=61 Participants Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor n=64 Participants Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor n=63 Participants Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor n=60 Participants Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor n=65 Participants Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand n=87 Participants Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Airway Inflammation (NIOX VERO)	18.94 ppb Standard Deviation 11.52	19.27 ppb Standard Deviation 13.38	18.95 ppb Standard Deviation 12.14	19.69 ppb Standard Deviation 11.86	18.52 ppb Standard Deviation 12.76	21.94 ppb Standard Deviation 19.51	19.20 ppb Standard Deviation 11.43	20.02 ppb Standard Deviation 12.55	18.77 ppb Standard Deviation 12.70

SECONDARY outcome

Timeframe: Baseline

Background measures. Comprised of 9 items each of which range 0-4 from "never" to "almost always". The 3 subscales (enjoyment of taste and smell, pleasurable physical sensations, enjoyment of vapor cloud production) are the average of 3 items each; scores range from 0 to 4 with higher scores indicating greater enjoyment.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=87 Participants Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Sensory E-Cigarette Expectancies Scale (SEES) Enjoyment of Taste and Smell	2.69 score on a scale Standard Deviation 0.77	—	—	—	—	—	—	—	—
Sensory E-Cigarette Expectancies Scale (SEES) Pleasurable Physical Sensations	2.76 score on a scale Standard Deviation 0.87	—	—	—	—	—	—	—	—
Sensory E-Cigarette Expectancies Scale (SEES) Enjoyment of Vapor Cloud Production	1.66 score on a scale Standard Deviation 1.06	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Participants who responded to all items on the modified cigarette dependence scale at baseline.

Assess e-cigarette dependence. Scores range from 5 to 25 with higher scores indicating a greater level of dependence.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=83 Participants Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Modified Cigarette Dependence Scale	17.37 score on a scale Standard Deviation 4.18	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 35 minutes

An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of UBMC and all three study products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=65 Participants Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor n=61 Participants Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor n=64 Participants Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor n=63 Participants Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor n=60 Participants Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor n=65 Participants Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand n=87 Participants Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Drug Effects/Liking Questionnaire Like	47.54 score on a scale Standard Deviation 25.32	35.36 score on a scale Standard Deviation 25.34	48.82 score on a scale Standard Deviation 27.28	41.94 score on a scale Standard Deviation 24.30	27.44 score on a scale Standard Deviation 27.40	17.08 score on a scale Standard Deviation 21.59	49.67 score on a scale Standard Deviation 27.13	31.51 score on a scale Standard Deviation 25.04	69.05 score on a scale Standard Deviation 21.81
Drug Effects/Liking Questionnaire Satisfying	44.89 score on a scale Standard Deviation 24.35	37.45 score on a scale Standard Deviation 23.26	48.84 score on a scale Standard Deviation 26.06	41.98 score on a scale Standard Deviation 25.56	33.95 score on a scale Standard Deviation 26.97	25.05 score on a scale Standard Deviation 23.64	52.48 score on a scale Standard Deviation 23.69	39.69 score on a scale Standard Deviation 26.24	74.33 score on a scale Standard Deviation 15.34
Drug Effects/Liking Questionnaire Want	40.40 score on a scale Standard Deviation 23.83	32.59 score on a scale Standard Deviation 23.08	44.69 score on a scale Standard Deviation 26.44	37.78 score on a scale Standard Deviation 22.14	27.48 score on a scale Standard Deviation 25.41	17.16 score on a scale Standard Deviation 21.13	43.58 score on a scale Standard Deviation 24.87	29.75 score on a scale Standard Deviation 24.76	45.40 score on a scale Standard Deviation 20.93
Drug Effects/Liking Questionnaire Enjoy	46.51 score on a scale Standard Deviation 25.12	36.70 score on a scale Standard Deviation 26.42	49.66 score on a scale Standard Deviation 27.01	43.02 score on a scale Standard Deviation 25.03	27.39 score on a scale Standard Deviation 26.77	18.27 score on a scale Standard Deviation 21.24	50.02 score on a scale Standard Deviation 25.74	31.42 score on a scale Standard Deviation 25.05	72.57 score on a scale Standard Deviation 17.73
Drug Effects/Liking Questionnaire Pleasurable	46.28 score on a scale Standard Deviation 24.26	36.42 score on a scale Standard Deviation 24.96	50.23 score on a scale Standard Deviation 26.53	44.66 score on a scale Standard Deviation 23.63	29.33 score on a scale Standard Deviation 27.92	18.60 score on a scale Standard Deviation 20.17	52.13 score on a scale Standard Deviation 25.00	34.48 score on a scale Standard Deviation 24.97	72.57 score on a scale Standard Deviation 15.94

SECONDARY outcome

Timeframe: 35 minutes

The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses to e-cigarettes (e.g., reward, satisfaction). The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=65 Participants Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor n=61 Participants Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor n=64 Participants Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor n=63 Participants Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor n=60 Participants Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor n=65 Participants Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Modified Cigarette Evaluation Questionnaire (mCEQ) Satisfaction	3.35 score on a scale Standard Deviation 1.32	2.78 score on a scale Standard Deviation 1.04	3.58 score on a scale Standard Deviation 1.31	2.97 score on a scale Standard Deviation 1.07	2.93 score on a scale Standard Deviation 1.33	2.26 score on a scale Standard Deviation 0.97	3.80 score on a scale Standard Deviation 1.39	2.93 score on a scale Standard Deviation 1.22	—
Modified Cigarette Evaluation Questionnaire (mCEQ) Reward	2.19 score on a scale Standard Deviation 0.99	2.17 score on a scale Standard Deviation 0.81	2.35 score on a scale Standard Deviation 1.10	2.23 score on a scale Standard Deviation 0.98	2.24 score on a scale Standard Deviation 1.13	2.01 score on a scale Standard Deviation 0.94	2.50 score on a scale Standard Deviation 1.18	2.32 score on a scale Standard Deviation 1.16	—
Modified Cigarette Evaluation Questionnaire (mCEQ) Aversion	1.18 score on a scale Standard Deviation 0.43	1.31 score on a scale Standard Deviation 0.57	1.29 score on a scale Standard Deviation 0.50	1.35 score on a scale Standard Deviation 0.95	1.63 score on a scale Standard Deviation 0.86	1.63 score on a scale Standard Deviation 0.74	1.73 score on a scale Standard Deviation 1.10	1.78 score on a scale Standard Deviation 1.25	—
Modified Cigarette Evaluation Questionnaire (mCEQ) Sensation	3.20 score on a scale Standard Deviation 1.55	2.55 score on a scale Standard Deviation 1.30	3.62 score on a scale Standard Deviation 1.66	2.83 score on a scale Standard Deviation 1.34	2.22 score on a scale Standard Deviation 1.50	1.73 score on a scale Standard Deviation 1.19	3.32 score on a scale Standard Deviation 1.57	2.77 score on a scale Standard Deviation 1.48	—
Modified Cigarette Evaluation Questionnaire (mCEQ) Craving	3.25 score on a scale Standard Deviation 1.58	3.17 score on a scale Standard Deviation 1.44	3.39 score on a scale Standard Deviation 1.38	3.23 score on a scale Standard Deviation 1.44	3.45 score on a scale Standard Deviation 1.58	2.97 score on a scale Standard Deviation 1.54	4.05 score on a scale Standard Deviation 1.68	3.40 score on a scale Standard Deviation 1.53	—

SECONDARY outcome

Timeframe: 35 minutes

Behavioral economic demand Asks participants how much they would be willing to pay (ranging from 0¢ to $1,120) for a puff of their study product. Specifically they will be asked, "Thinking about the study product, how many puffs of e-cigarette would you smoke if they were each at the following prices?". Breakpoint is the first price of zero consumption.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=65 Participants Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor n=61 Participants Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor n=64 Participants Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor n=63 Participants Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor n=60 Participants Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor n=65 Participants Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand n=86 Participants Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
E-cigarette Purchase Task - Breakpoint	0.5 Dollars Interval 0.25 to 2.0	0.38 Dollars Interval 0.05 to 2.5	1 Dollars Interval 0.25 to 3.0	0.5 Dollars Interval 0.25 to 3.0	0.5 Dollars Interval 0.13 to 4.0	0.25 Dollars Interval 0.0 to 2.0	1 Dollars Interval 0.25 to 3.5	0.5 Dollars Interval 0.13 to 2.0	2.0 Dollars Interval 0.5 to 6.0

SECONDARY outcome

Timeframe: 0, 5, 10, 35 min.

Population: Participants who attended the study product visit and fully completed the QSU items

E-cig craving/suppression of craving and withdraw will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges (QSU): Brief Form with a modified version (replacing the word "cigarette" with "e-cigarette"). This is a 10-item measure where participants rate smoking/vaping-related items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving to smoke/vape.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=65 Participants Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor n=61 Participants Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor n=64 Participants Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor n=64 Participants Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor n=63 Participants Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor n=60 Participants Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor n=65 Participants Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand n=87 Participants Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form QSU Relief: 0min	13.78 units on a scale Standard Deviation 7.18	13.88 units on a scale Standard Deviation 7.02	14.28 units on a scale Standard Deviation 7.18	14.08 units on a scale Standard Deviation 7.22	13.69 units on a scale Standard Deviation 7.14	13.68 units on a scale Standard Deviation 6.83	13.25 units on a scale Standard Deviation 7.35	13.80 units on a scale Standard Deviation 7.74	15.64 units on a scale Standard Deviation 6.92
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form QSU Relief: 5min	10.77 units on a scale Standard Deviation 6.14	10.56 units on a scale Standard Deviation 5.40	10.98 units on a scale Standard Deviation 5.82	10.77 units on a scale Standard Deviation 5.39	10.08 units on a scale Standard Deviation 5.58	10.35 units on a scale Standard Deviation 5.91	9.95 units on a scale Standard Deviation 5.40	10.02 units on a scale Standard Deviation 4.97	9.95 units on a scale Standard Deviation 4.84
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form QSU Desire: 10 min	17.49 units on a scale Standard Deviation 8.04	17.22 units on a scale Standard Deviation 6.96	17.64 units on a scale Standard Deviation 7.54	17.73 units on a scale Standard Deviation 7.46	15.29 units on a scale Standard Deviation 7.11	16.56 units on a scale Standard Deviation 7.56	15.15 units on a scale Standard Deviation 6.88	15.74 units on a scale Standard Deviation 6.83	13.76 units on a scale Standard Deviation 6.75
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form QSU Relief: 10 min	9.92 units on a scale Standard Deviation 5.82	10.03 units on a scale Standard Deviation 4.97	9.93 units on a scale Standard Deviation 5.44	9.92 units on a scale Standard Deviation 5.13	9.23 units on a scale Standard Deviation 4.71	9.71 units on a scale Standard Deviation 5.30	9.37 units on a scale Standard Deviation 4.96	9.66 units on a scale Standard Deviation 4.84	9.40 units on a scale Standard Deviation 5.05
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form QSU Desire: 35 min	16.17 units on a scale Standard Deviation 7.94	16.72 units on a scale Standard Deviation 7.68	16.87 units on a scale Standard Deviation 7.02	16.88 units on a scale Standard Deviation 7.79	15.41 units on a scale Standard Deviation 7.15	16.54 units on a scale Standard Deviation 7.65	14.55 units on a scale Standard Deviation 6.45	14.92 units on a scale Standard Deviation 7.48	12.49 units on a scale Standard Deviation 5.83
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form QSU Desire: 0min	24.85 units on a scale Standard Deviation 8.27	25.44 units on a scale Standard Deviation 7.02	25.51 units on a scale Standard Deviation 7.43	25.56 units on a scale Standard Deviation 7.15	24.52 units on a scale Standard Deviation 7.26	25.25 units on a scale Standard Deviation 7.55	24.03 units on a scale Standard Deviation 7.85	24.09 units on a scale Standard Deviation 7.97	26.18 units on a scale Standard Deviation 7.44
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form QSU Desire: 5 min	18.92 units on a scale Standard Deviation 7.63	18.38 units on a scale Standard Deviation 6.78	19.54 units on a scale Standard Deviation 7.43	19.00 units on a scale Standard Deviation 7.50	16.34 units on a scale Standard Deviation 7.47	17.44 units on a scale Standard Deviation 7.74	16.78 units on a scale Standard Deviation 7.02	16.98 units on a scale Standard Deviation 7.13	14.45 units on a scale Standard Deviation 6.85
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form QSU Relief: 35 min	9.57 units on a scale Standard Deviation 5.51	9.58 units on a scale Standard Deviation 4.63	9.41 units on a scale Standard Deviation 4.68	9.28 units on a scale Standard Deviation 4.53	8.94 units on a scale Standard Deviation 4.56	9.38 units on a scale Standard Deviation 4.45	8.40 units on a scale Standard Deviation 3.82	8.95 units on a scale Standard Deviation 4.55	8.09 units on a scale Standard Deviation 4.29

SECONDARY outcome

Timeframe: Pre-Vaping Session at Visit 1

Population: Participants who attended the baseline study visit and whose endothelial function was able to be recorded with the EndoPAT device.

Endothelial function will be collected through EndoPAT device. Specifically, the natural log of RHI, the reactive hyperemia index, will be recorded. The RHI (Reactive Hyperemia Index) or LnRHI (natural log of RHI) is the post-to-pre occlusion PAT™ signal ratio in the occluded arm, relative to the same ratio in the control arm, corrected for baseline vascular tone. Values less than 1.67 or higher than 0.51 are considered to be abnormal.

Outcome measures

Outcome measures
Measure	Low Concentration Free-base Nicotine (1%), Menthol Flavor n=86 Participants Participate in vaping session with menthol flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Free-base Nicotine (1%), Tobacco Flavor Participate in vaping session with tobacco flavored low concentration free-base nicotine (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Menthol Flavor Participate in vaping session with menthol flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Low Concentration Nicotine Salt (1%), Tobacco Flavor Participate in vaping session with tobacco flavored low concentration nicotine salt (1%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Menthol Flavor Participate in vaping session with menthol flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Free-base Nicotine (5%), Tobacco Flavor Participate in vaping session with tobacco flavored high concentration free-base nicotine (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Menthol Flavor Participate in vaping session with menthol flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	High Concentration Nicotine Salt (5%), Tobacco Flavor Participate in vaping session with tobacco flavored high concentration nicotine salt (5%) e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.	Usual Brand Participate in vaping session with their usual brand e-cigarette including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
Vascular Reactivity	0.47 ratio Standard Deviation 0.26	—	—	—	—	—	—	—	—

Additional Information

Dr. Theodore L. Wagener

OhioSUCCC

Phone: 614-366-4265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place