Impact of Menthol on E-Cigarette Users' Addiction and Exposure
The Effect of Menthol on ENDS Users' Dependence, Respiratory, and Toxicants Emission Outcomes.
This study is testing how menthol-flavored e-cigarettes affect addiction and exposure to harmful substances in young adults aged 21-35.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 21 Years to 35 Years |
| Sex | All |
| Sponsor | Florida International University Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05338801 on ClinicalTrials.gov |
What this trial studies
This study investigates how menthol-flavored e-cigarettes affect addiction levels and exposure to harmful substances among users aged 21-35. It aims to understand the influence of menthol on puffing patterns and nicotine dependence, particularly in the context of rising e-cigarette use among young people. Participants will be required to abstain from e-cigarette use for 12 hours before each session, during which they will use either menthol or tobacco-flavored e-cigarettes. The findings could provide insights into the health implications of menthol in e-cigarettes and inform regulatory decisions.
Who should consider this trial
Good fit: Ideal candidates for this study are generally healthy e-cigarette users aged 21-35 who have abstained from e-cigarette use for 12 hours prior to each session.
Not a fit: Patients who smoke cigarettes regularly or use other tobacco products may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and regulation of menthol-flavored e-cigarettes, potentially reducing addiction and health risks for users.
How similar studies have performed: While there is ongoing research into the effects of flavoring in tobacco products, the specific focus on menthol in e-cigarettes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Generally healthy individuals (determined by physical examination). * Age of 21-35 years. * Is willing to provide informed consent. * Is willing to attend the lab as required by the study protocol. * E-cigarette users (defined as using e-cigarette either daily or occasionally in the past 30 days) * Have abstained from e-cigarette use for 12 hours prior to each session Exclusion Criteria: * Report smoking cigarettes regularly (\> 5 cigarettes/month in the past year). * Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year. * Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening). * Individuals with self-reported history of chronic disease or psychiatric conditions. * Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control). * Individuals that report current THC (marijuana) smoking/vaping. * Individuals that report current EVALI or COVID-19 related symptoms (i.e., cough, shortness of breath, chest pain, nausea, vomiting, abdominal pain, diarrhea, fever, chills, or weight loss) * Individuals that have or have been exposed to COVID-19 in the last 14 days.
Where this trial is running
Miami, Florida
- Florida International University — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Wasim Maziak, PhD, MD — Florida International University
- Study coordinator: Wasim Maziak, PhD, MD
- Email: wmaziak@fiu.edu
- Phone: 3053484501
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.