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Testing the Effect of ENDS Flavors on Neurotransmission

Testing the Effect of ENDS Flavors on Neurotransmission

Non Recruiting
21 years and older
All
Phase N/A

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Overview

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.

Description

For this randomized double-blind controlled trial, tobacco users will be randomized to use ENDS with an e-liquid containing a neuroactive green-apple flavor (hexyl acetate) vs. an inactive green-apple 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

Inclusion Criteria:

  1. 21 years old or older
  2. Weekly user of inhaled tobacco products, including inhaled ENDS, nicotine vapes, cigarettes, regular and little cigars for at least last three months
  3. Not planning to quit tobacco use within next month
  4. Able to read and write in English

Exclusion Criteria:

  1. Current substance use impairing participation
  2. Unstable or significant medical conditions (e.g., COPD, coronary heart disease)
  3. Current use of smoking cessation medication (e.g., varenicline, patch)
  4. Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
  5. Unable or unwilling to abstain from nicotine products for 14 hours prior to the scheduled visit, self-reported.

MRI-specific exclusion criteria:

  1. MRI safety contraindications (e.g., metal implants, claustrophobia)
  2. Major neurological conditions or brain trauma

Study details
    Tobacco Dependence

NCT05836051

Milton S. Hershey Medical Center

21 October 2025

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