Effect of Menthol on ENDS Users' Addiction and Exposure

Launched by FLORIDA INTERNATIONAL UNIVERSITY · Apr 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of menthol versus tobacco flavor in electronic cigarette users, especially how these flavors might influence addiction and exposure to harmful substances. The researchers want to understand if menthol, which is popular among young people, increases the risk of addiction and toxic exposure compared to traditional tobacco flavor. This information is important for the FDA as they consider ways to regulate flavored e-cigarettes to protect public health.

To participate in this study, you need to be a generally healthy adult aged 21 to 35 who has used e-cigarettes in the past month. You must be willing to attend two lab sessions and refrain from using e-cigarettes for 12 hours before each session. During the study, you'll try both menthol and tobacco flavors in a controlled setting. The researchers will collect information on how these flavors affect your vaping behavior, satisfaction, and any changes in your desire to quit. Your participation could help inform important decisions about the safety and regulation of flavored e-cigarettes.

Gender

ALL

Eligibility 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.