Testing the Effect of ENDS Flavors on Neurotransmission
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tobacco Dependence
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Brain reward reactivity
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Andrea Hobkirk, PhD
Assistant Professor
Penn State University
Eligibility Criteria
Inclusion Criteria
- •21 years old or older
- •Weekly user of inhaled tobacco products, including inhaled ENDS, nicotine vapes, cigarettes, regular and little cigars for at least last three months
- •Not planning to quit tobacco use within next month
- •Able to read and write in English
Exclusion Criteria
- •Current substance use impairing participation
- •Unstable or significant medical conditions (e.g., COPD, coronary heart disease)
- •Current use of smoking cessation medication (e.g., varenicline, patch)
- •Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
- •Unable or unwilling to abstain from nicotine products for 14 hours prior to the scheduled visit, self-reported.
- •MRI-specific exclusion criteria:
- •MRI safety contraindications (e.g., metal implants, claustrophobia)
- •Major neurological conditions or brain trauma
Outcomes
Primary Outcomes
Brain reward reactivity
Time Frame: 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
Time Frame: 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