Penn State Health
Hershey, Pennsylvania, 17033, United States
NCT Number: NCT05836051
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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Notify Me21 year–60 year
All sexes
Interventional
Not applicable
Hershey, Pennsylvania, 17033, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MRI-specific exclusion criteria:
E-liquid flavor chemicals
Time frame: Pre to post-intervention (approximately 10 days)
Brain reward reactivity will be calculated as the difference in the percent of BOLD signal calculated by subtracting the absolute percentage at the post-scan from baseline in a pre-defined ventral tegmental area (VTA) region of interest during electronic nicotine delivery system (ENDS) inhalation.
Time frame: Pre to post-intervention (approximately 10 days)
Absolute reinforcement will be calculated as the mean difference in puffs per day calculated as the average puffs per day during last four days minus the first four days of the 10-day use period.
Milton S. Hershey Medical Center
Other
Acronym: TEN
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