Testing the Effect of ENDS Flavors on Neurotransmission

Tobacco Dependence Clinical Trial

— TEN  

Official title:

Testing the Effect of ENDS Flavors on Neurotransmission

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05836051
• Other study ID #: 19883
• Secondary ID: R61DA056764
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Milton S. Hershey Medical Center
• Contact: Andrea Hobkirk, PhD
• Phone: 717-531-0003
• Email: ahobkirk[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

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

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Other:
• Flavor
E-liquid flavor chemicals

Locations

Country	Name	City	State
United States	Penn State Health	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pre to post-intervention (approximately 10 days)
Primary	Absolute reinforcement	Absolute reinforcement will be calculated as the change in the average number of puffs per day during a 10-day use period	Pre to post-intervention (approximately 10 days)