Effects of E-Cigarette Flavors on Adults TCORS 2.0
2 other identifiers
interventional
130
1 country
1
Brief Summary
This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedStudy Start
First participant enrolled
May 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2023
CompletedResults Posted
Study results publicly available
December 19, 2025
CompletedDecember 19, 2025
December 1, 2025
4.2 years
August 13, 2018
July 8, 2024
December 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change Score in Liking/Wanting of E-cigarette
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)
Baseline (+10 minutes) to end of lab session (+40 minutes)
Study Arms (8)
Low nicotine, tobacco
EXPERIMENTAL6 mg nicotine combined with tobacco flavored e-juice
Low nicotine, menthol
EXPERIMENTAL6 mg nicotine combined with menthol flavored e-juice
Low nicotine,cherry
EXPERIMENTAL6 mg nicotine combined with cherry flavored e-juice
High nicotine, tobacco
EXPERIMENTAL18 mg nicotine combined with tobacco flavored e-juice
High nicotine, menthol
EXPERIMENTAL18 mg nicotine combined with menthol flavored e-juice
High Nicotine, cherry
EXPERIMENTAL18 mg nicotine combined with cherry flavored e-juice
Low Nicotine, Vanilla
EXPERIMENTAL6 mg nicotine combined with vanilla flavored e-juice
High Nicotine, Vanilla
EXPERIMENTAL18 mg nicotine combined with vanilla flavored e-juice
Interventions
Nicotine level (6 or 18 mg)
Flavor of e-juice (tobacco, menthol, cherry, vanilla)
Eligibility Criteria
You may qualify if:
- Ages 21-34 years or 35 -50 years
- Able to read and write
- Smoking \>/= 1 cigarettes or cigars/day
- Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes
- Not seeking treatment to stop smoking
You may not qualify if:
- Daily use of other drugs including prescribed psychoactive drugs
- Any significant current medical or psychiatric condition
- Known hypersensitivity to propylene glycol
- Pregnant or lactating females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
CMHC, Substance Abuse Center
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Danielle Davis
- Organization
- Yale University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2018
First Posted
August 17, 2018
Study Start
May 14, 2019
Primary Completion
July 12, 2023
Study Completion
July 12, 2023
Last Updated
December 19, 2025
Results First Posted
December 19, 2025
Record last verified: 2025-12