Testing the Effect of ENDS Flavors on Neurotransmission

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Hexyl Acetate

E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.

Group Type EXPERIMENTAL

Flavor

Intervention Type OTHER

E-liquid flavor chemicals

Ethyl Acetate

E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.

Group Type ACTIVE_COMPARATOR

Flavor

Intervention Type OTHER

E-liquid flavor chemicals

Interventions

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Flavor

E-liquid flavor chemicals

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No