Testing the Effect of ENDS Flavors on Neurotransmission

Milton S. Hershey Medical Center36 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Tobacco Dependence

Interventions

FlavorOTHER

E-liquid flavor chemicals

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 MRI-specific exclusion criteria: 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

Outcomes

Primary Outcomes

Brain reward reactivity

Brain reward reactivity will be calculated as the percent change in average blood oxygen-level dependent (BOLD) signal in a pre-defined ventral tegmental area (VTA) region of interest during ENDS inhalation

Time frame: Pre to post-intervention (approximately 10 days)

Absolute reinforcement

Absolute reinforcement will be calculated as the change in the average number of puffs per day during a 10-day use period

Time frame: Pre to post-intervention (approximately 10 days)

Data from ClinicalTrials.gov

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