TEN: Testing the Effect of ENDS Flavors on Neurotransmission

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05836051
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Dependence	Other: Flavor	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: Testing the Effect of ENDS Flavors on Neurotransmission
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hexyl Acetate E-cigarette liquid containing hexyl acetate, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.	Other: Flavor; E-liquid flavor chemicals
Active Comparator: Ethyl Acetate E-cigarette liquid containing ethyl acetate, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.	Other: Flavor; E-liquid flavor chemicals

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Health	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center
• National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea Hobkirk, PhD, Assistant Professor, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT05836051
• Other Study ID Numbers: 19883; R61DA056764
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andrea Hobkirk, PhD, Assistant Professor, Milton S. Hershey Medical Center: Tobacco; Nicotine; Smoking; Addiction
• Additional relevant MeSH terms: Tobacco Use Disorder

Study Results

No Results Posted as of May 1, 2023