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OpenTrials
Completed

NCT Number: NCT03635333

Effects of E-Cigarette Flavors on Adults TCORS 2.0

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

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMHC, Substance Abuse Center

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

nicotine

Drug

Nicotine level (6 or 18 mg)

Flavor

Drug

Flavor of e-juice (tobacco, menthol, cherry, vanilla)

Primary outcomes

  1. Change Score in Liking/Wanting of E-cigarette

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Effects of E-Cigarette Flavors on Adults

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2018
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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