NCT03635333

Effects of E-Cigarette Flavors on Adults TCORS 2.0

Completed Phase 1 Results posted Last updated 19 December 2025

What this trial tests

Phase 1 trial testing Nicotine in Nicotine Use Disorder in 130 participants. Completed in 12 July 2023.

Timeline

14 May 2019

Primary endpoint
12 July 2023

12 July 2023

Quick facts

Lead sponsor	Yale University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	130
Start date	14 May 2019
Primary completion	12 July 2023
Estimated completion	12 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Nicotine (NICOTINE) — full drug profile →
• Flavor — full drug profile →

Conditions studied

• Nicotine Use Disorder — all drugs for Nicotine Use Disorder →

Sponsor

Yale University

Who can join

Adults 21 to 50, any sex, with Nicotine Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change Score in Liking/Wanting of E-cigarette Primary · Baseline (+10 minutes) to end of lab session (+40 minutes)

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)

Group	Value	95% CI
Low Nicotine, Tobacco	-1.06	± 4.68
Low Nicotine, Menthol	-5.59	± 4.67
Low Nicotine,Cherry	-7.14	± 4.8
High Nicotine, Tobacco	-7.63	± 4.72
High Nicotine, Menthol	8.41	± 4.73
High Nicotine, Cherry	0.42	± 4.78
Low Nicotine, Vanilla	4.77	± 4.65
High Nicotine, Vanilla	5.48	± 4.74

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vanilla Low Nicotine Group (6mg/ml)

Serious: 0/55 (0%)

Deaths: 0/55

Vanilla High Nicotine Group (18mg/ml)

Serious: 0/52 (0%)

Deaths: 0/52

Cherry Low Nicotine Group (6mg/ml)

Serious: 0/51 (0%)

Deaths: 0/51

Cherry High Nicotine Group (18mg/ml)

Serious: 0/51 (0%)

Deaths: 0/51

Tobacco Low Nicotine Group (6mg/ml)

Serious: 0/59 (0%)

Deaths: 0/59

Tobacco High Nicotine Group (18mg/ml)

Serious: 0/57 (0%)

Deaths: 0/57

Menthol Low Nicotine Group (6mg/ml)

Serious: 0/59 (0%)

Deaths: 0/59

Menthol High Nicotine Group (18mg/ml)

Serious: 0/56 (0%)

Deaths: 0/56

Randomized Non-Starter Low Nicotine Group (6mg/ml)

Serious: 0/8 (0%)

Deaths: 0/8

Randomized Non-starter High Nicotine Group (18mg/ml)

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (2 terms — click to expand)

Reaction	System	Vanilla Low Nicotine Group…	Vanilla High Nicotine Grou…	Cherry Low Nicotine Group …	Cherry High Nicotine Group…	Tobacco Low Nicotine Group…	Tobacco High Nicotine Grou…	Menthol Low Nicotine Group…	Menthol High Nicotine Grou…	Randomized Non-Starter Low…	Randomized Non-starter Hig…
Other	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—
Other	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT03635333 adverse events section.

Sponsor's own description

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sex differences in appeal, reward, and sensory experience of E-cigarette flavors among adults who smoke cigarettes.
   Davis DR, Buta E, Green B, Krishnan-Sarin S. · · 2024 · cited 5× · PMID 38866212 · DOI 10.1016/j.ypmed.2024.108040