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COMPLETEDNA

Testing the Effect of ENDS Flavors on Neurotransmission

NCT05836051•Milton S. Hershey Medical Center

Summary

The overarching goal of this translational proposal is to determine if neuroactive flavor chemicals can enhance the addiction potential of electronic nicotine delivery systems (ENDS) by altering brain function and behavior.

Detailed Description

For this randomized double-blind controlled trial, tobacco users will be randomized to use ENDS with an e-liquid containing a neuroactive flavor (hexyl acetate) vs. an inactive flavor (ethyl acetate) for ten days as a supplement to their typical tobacco use. Laboratory measures of ENDS reinforcement, subjective ENDS ratings, and brain reactivity to the flavor using functional magnetic resonance imaging (fMRI) will be collected at baseline and after ten days of ENDS use.

Eligibility

Age

21 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 21 to 60 years old
•2. Regular users of inhaled tobacco products (≥5 days out of the last 28)
•3. Not planning to quit tobacco use within next month
•4. Able to read and write in English

Exclusion Criteria

•1. Major neurological conditions or brain trauma
•2. Current substance use impairing participation
•3. Unstable or significant medical conditions (e.g., COPD, coronary heart disease)
•4. Current use of smoking cessation medication (e.g., varenicline, patch)
•5. Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
•6. Known allergic reaction to ENDS liquids ingredients propylene glycol or vegetable glycerin
•7. Unable to use study provided ENDS ad-libitum for at least 3 hours per day
•8. Pregnant or breastfeeding as indicated by self-report or urine pregnancy screen
•1. MRI safety contraindications (e.g., metal implants, claustrophobia)
•2. Major neurological conditions or brain trauma

Locations (1)

Penn State Health

Hershey, Pennsylvania, United States

Key Dates

Start Date

June 1, 2023

Primary Completion Date

May 30, 2025

Completion Date

July 31, 2025

Last Updated

September 25, 2025

Enrollment

ACTUAL participants

Conditions

Tobacco Dependence

Interventions

Flavor

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Testing the Effect of ENDS Flavors on Neurotransmission

Inclusion Criteria

Exclusion Criteria

Harm Reduction for Smokers With Mental Illness

Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals

Cannabidiol for Reducing Cigarette Use

Assessment of Biomarkers in Children to Help Parents Quit Tobacco

Varenicline for Smoking Reduction in Veterans Not Ready To Quit

ICARE-LCS QUERI Partnered Evaluation Initiative: Integrating Comprehensive Tobacco Treatment to Enhance Lung Cancer Screening