Testing the Effect of ENDS Flavors on Neurotransmission

Not Applicable

Recruiting

• Conditions: Tobacco Dependence
• Interventions: Other: Flavor

• Registration Number: NCT05836051
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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 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.

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-05-01
• Study Start: 2023-06-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hexyl Acetate	Flavor	E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
Ethyl Acetate	Flavor	E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.

Primary Outcome Measures

Name	Time	Method
Brain reward reactivity	Pre to post-intervention (approximately 10 days)	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
Absolute reinforcement	Pre to post-intervention (approximately 10 days)	Absolute reinforcement will be calculated as the change in the average number of puffs per day during a 10-day use period

Trial Locations

Locations (1)

Penn State Health; 🇺🇸 Hershey, Pennsylvania, United States