Testing the Effect of ENDS Flavors on Neurotransmission

Launched by MILTON S. HERSHEY MEDICAL CENTER · Apr 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how different flavors in electronic nicotine delivery systems (ENDS), like e-cigarettes, might affect the brain and increase the chances of becoming addicted to these products. Researchers want to understand if the flavors can change brain function and behavior in people who regularly use tobacco.

To join this study, participants need to be between 21 and 60 years old and must have used inhaled tobacco products, like e-cigarettes, on at least five days in the past month. They should not plan to quit using tobacco in the next month and must be able to read and write in English. Participants will have the chance to use the flavored ENDS for about three hours a day while being monitored. It's important to note that individuals with certain medical conditions, current substance use issues, or those who are pregnant or breastfeeding cannot participate. This trial is currently recruiting participants, and everyone is welcome to apply, regardless of gender.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 21 to 60 years old
• • 2. Regular users of inhaled tobacco products (≥5 days out of the last 28)
• • 3. Not planning to quit tobacco use within next month
• • 4. Able to read and write in English
• Exclusion Criteria:
• • 1. Major neurological conditions or brain trauma
• • 2. Current substance use impairing participation
• • 3. Unstable or significant medical conditions (e.g., COPD, coronary heart disease)
• • 4. Current use of smoking cessation medication (e.g., varenicline, patch)
• • 5. Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
• • 6. Known allergic reaction to ENDS liquids ingredients propylene glycol or vegetable glycerin
• • 7. Unable to use study provided ENDS ad-libitum for at least 3 hours per day
• • 8. Pregnant or breastfeeding as indicated by self-report or urine pregnancy screen
• MRI-specific exclusion criteria:
• • 1. MRI safety contraindications (e.g., metal implants, claustrophobia)
• • 2. Major neurological conditions or brain trauma