Trial Outcomes & Findings for Effects of E-Cigarette Flavors on Adults TCORS 2.0 (NCT NCT03635333)

Last Updated: 2025-12-19

Results Overview

The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale \[range -100 to 100\] with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

130 participants

Primary outcome timeframe

Baseline (+10 minutes) to end of lab session (+40 minutes)

Results posted on

2025-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	High Nicotine 18 mg nicotine	Low Nicotine 6mg/ml nicotine
Overall Study STARTED	63	67
Overall Study Vanilla Flavor	52	55
Overall Study Cherry Flavor	51	51
Overall Study Menthol Flavor	57	59
Overall Study Tobacco Flavor	56	59
Overall Study COMPLETED	58	56
Overall Study NOT COMPLETED	5	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of E-Cigarette Flavors on Adults TCORS 2.0

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Nicotine Group (6mg/ml) n=62 Participants Participants that were assigned to the low nicotine condition and exposed to tobacco, menthol, cherry, and vanilla.	High Nicotine Group (18mg/ml) n=59 Participants Participants that were assigned to the high nicotine condition and exposed to tobacco, menthol, cherry, and vanilla.	Total n=121 Participants Total of all reporting groups
Age, Continuous	36.0 years STANDARD_DEVIATION 8.8 • n=8 Participants	35.8 years STANDARD_DEVIATION 7.5 • n=6 Participants	35.9 years STANDARD_DEVIATION 8.1 • n=6 Participants
Sex: Female, Male Female	25 Participants n=8 Participants	21 Participants n=6 Participants	46 Participants n=6 Participants
Sex: Female, Male Male	37 Participants n=8 Participants	38 Participants n=6 Participants	75 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=8 Participants	4 Participants n=6 Participants	13 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=8 Participants	55 Participants n=6 Participants	108 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	5 Participants n=8 Participants	4 Participants n=6 Participants	9 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	10 Participants n=8 Participants	10 Participants n=6 Participants	20 Participants n=6 Participants
Race (NIH/OMB) White	42 Participants n=8 Participants	37 Participants n=6 Participants	79 Participants n=6 Participants
Race (NIH/OMB) More than one race	4 Participants n=8 Participants	4 Participants n=6 Participants	8 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=8 Participants	4 Participants n=6 Participants	5 Participants n=6 Participants
Region of Enrollment United States	62 participants n=8 Participants	59 participants n=6 Participants	121 participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline (+10 minutes) to end of lab session (+40 minutes)

Population: The study started in May 2019 and the study was active between May 2019 and October 2020 and 9 participants were enrolled. However, due to study changes communicated previously, analyses only reflect enrolled participants who completed the study following the study protocol change (i.e., addition of a laboratory session in October 2020). Randomized non-starters were excluded from analyses (n=8, 5 low nicotine, 3 high nicotine). Those who completed at least one lab had data included in analyses

Outcome measures

Outcome measures
Measure	Low Nicotine, Tobacco n=53 Participants 6 mg nicotine combined with tobacco flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)	Low Nicotine, Menthol n=53 Participants 6 mg nicotine combined with menthol flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)	Low Nicotine,Cherry n=53 Participants 6 mg nicotine combined with cherry flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)	High Nicotine, Tobacco n=54 Participants 18 mg nicotine combined with tobacco flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)	High Nicotine, Menthol n=54 Participants 18 mg nicotine combined with menthol flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)	High Nicotine, Cherry n=55 Participants 18 mg nicotine combined with cherry flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)	Low Nicotine, Vanilla n=52 Participants 6 mg nicotine combined with vanilla flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)	High Nicotine, Vanilla n=53 Participants 18 mg nicotine combined with vanilla flavored e-juice Nicotine: Nicotine level (6 or 18 mg) Flavor: Flavor of e-juice (tobacco, menthol, cherry, vanilla)
Change Score in Liking/Wanting of E-cigarette	-1.06 units on scale Standard Error 4.68	-5.59 units on scale Standard Error 4.67	-7.14 units on scale Standard Error 4.8	-7.63 units on scale Standard Error 4.72	8.41 units on scale Standard Error 4.73	0.42 units on scale Standard Error 4.78	4.77 units on scale Standard Error 4.65	5.48 units on scale Standard Error 4.74

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vanilla Low Nicotine Group (6mg/ml) n=55 participants at risk Participants who were assigned to the low nicotine condition and were exposed to vanilla flavor.	Vanilla High Nicotine Group (18mg/ml) n=52 participants at risk Participants who were assigned to the high nicotine condition and were exposed to vanilla flavor.	Cherry Low Nicotine Group (6mg/ml) n=51 participants at risk Participants who were assigned to the low nicotine condition and were exposed to cherry flavor.	Cherry High Nicotine Group (18mg/ml) n=51 participants at risk Participants who were assigned to the high nicotine condition and were exposed to cherry flavor.	Tobacco Low Nicotine Group (6mg/ml) n=59 participants at risk Participants who were assigned to the low nicotine condition and were exposed to tobacco flavor.	Tobacco High Nicotine Group (18mg/ml) n=57 participants at risk Participants who were assigned to the high nicotine condition and were exposed to tobacco flavor.	Menthol Low Nicotine Group (6mg/ml) n=59 participants at risk Participants who were assigned to the low nicotine condition and were exposed to menthol flavor.	Menthol High Nicotine Group (18mg/ml) n=56 participants at risk Participants who were assigned to the high nicotine condition and were exposed to menthol flavor.	Randomized Non-Starter Low Nicotine Group (6mg/ml) n=8 participants at risk Participants who were randomized to the low nicotine condition and enrolled in the trial but did not start lab and thus had no flavor exposure	Randomized Non-starter High Nicotine Group (18mg/ml) n=6 participants at risk Participants who were randomized to the high nicotine condition and enrolled in the trial but did not start lab and thus had no flavor exposure
Respiratory, thoracic and mediastinal disorders Other	0.00% 0/55 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/52 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/51 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/51 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	1.7% 1/59 • Number of events 1 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/57 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/59 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/56 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/8 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/6 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.
Skin and subcutaneous tissue disorders Other	0.00% 0/55 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/52 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	2.0% 1/51 • Number of events 1 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/51 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/59 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/57 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/59 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/56 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/8 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.	0.00% 0/6 • Adverse events for each participant were recorded from the start of their participant to completion (6 month follow up phone call), on average 6 months.

Additional Information

Danielle Davis

Yale University School of Medicine

Phone: 2039747607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place