Clinical Trials Directory

Trials / Completed

CompletedNCT03635333

Effects of E-Cigarette Flavors on Adults TCORS 2.0

Effects of E-Cigarette Flavors on Adults

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
130 (actual)
Sponsor
Yale University · Academic / Other
Sex
All
Age
21 Years – 50 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence. As of October 2020, this protocol was updated in which an additional lab session was added. Participants are to complete 4 lab sessions in which they will use an e-cigarette and complete questionnaires. In each individual lab session, they will sample one of the following four e-liquids: cherry, vanilla, menthol, tobacco. Additionally, participant age range was shifted to 21-50 with the younger condition being 21-34 and older being 35-50 and cigarette requirement was at least 1 cigarette/day at this time to be more representative of current persons who smoke.

Conditions

Interventions

TypeNameDescription
DRUGNicotineNicotine level (6 or 18 mg)
DRUGFlavorFlavor of e-juice (tobacco, menthol, cherry, vanilla)

Timeline

Start date
2019-05-14
Primary completion
2023-07-12
Completion
2023-07-12
First posted
2018-08-17
Last updated
2025-12-19
Results posted
2025-12-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03635333. Inclusion in this directory is not an endorsement.