Effects of E-Cigarette Flavors on Adults TCORS 2.0

Effects of E-Cigarette Flavors on Adults

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

Study Overview

• Status: Completed
• Conditions: Nicotine Use Disorder
• Intervention / Treatment: Drug: Nicotine; Drug: Flavor

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • CMHC, Substance Abuse Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low nicotine, tobacco; 6 mg nicotine combined with tobacco flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, cherry, vanilla)
Experimental: Low nicotine, menthol; 6 mg nicotine combined with menthol flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, cherry, vanilla)
Experimental: High nicotine, tobacco; 18 mg nicotine combined with tobacco flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, cherry, vanilla)
Experimental: High nicotine, menthol; 18 mg nicotine combined with menthol flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, cherry, vanilla)
Experimental: Low nicotine,cherry; 6 mg nicotine combined with cherry flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, cherry, vanilla)
Experimental: High Nicotine, cherry; 18 mg nicotine combined with cherry flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, cherry, vanilla)
Experimental: Low Nicotine, Vanilla; 6 mg nicotine combined with vanilla flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, cherry, vanilla)
Experimental: High Nicotine, Vanilla; 18 mg nicotine combined with vanilla flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, cherry, vanilla)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2019
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Alkaloids; Specialty Uses of Chemicals; Pharmaceutic Aids; Solanaceous Alkaloids; Food Additives; Food Ingredients; Nicotine; Flavoring Agents
• Other Study ID Numbers: 2000023077-2; 2U54DA036151-06 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No