Testing how flavors in e-cigarettes affect brain function and addiction
Testing the Effect of ENDS Flavors on Neurotransmission
NA · Milton S. Hershey Medical Center · NCT05836051
This study is testing if certain flavors in e-cigarettes can make it easier for regular tobacco users to become addicted by affecting how their brains work.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center (other) |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT05836051 on ClinicalTrials.gov |
What this trial studies
This interventional trial aims to investigate whether neuroactive flavor chemicals in electronic nicotine delivery systems (ENDS) can increase the addiction potential of these products by influencing brain function and behavior. Participants, who are regular tobacco users, will be randomly assigned to use ENDS with either a neuroactive flavor (hexyl acetate) or an inactive flavor (ethyl acetate) for ten days. The study will measure the reinforcement of ENDS use, subjective ratings, and brain reactivity through functional magnetic resonance imaging (fMRI) before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 to 60 who regularly use inhaled tobacco products and are not planning to quit in the near future.
Not a fit: Patients with major neurological conditions, unstable medical conditions, or those currently using smoking cessation medications are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how flavors in e-cigarettes may enhance addiction, potentially informing better regulation and treatment strategies for tobacco dependence.
How similar studies have performed: While the specific focus on neuroactive flavors in ENDS is relatively novel, previous studies have explored the impact of flavors on tobacco addiction with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hershey, Pennsylvania
- Penn State Health — Hershey, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Andrea Hobkirk, PhD
- Email: ahobkirk@pennstatehealth.psu.edu
- Phone: 717-531-7279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tobacco Dependence, Tobacco, Nicotine, Smoking, Addiction