Effect of Menthol on ENDS Users' Addiction and Exposure
The use of electronic nicotine delivery systems (ENDS; e-cigarettes) has reached epidemic levels among young people in the United States (US). ENDS heat and vaporize a nicotine-containing liquid to produce an inhalable aerosol mist. While generally considered less harmful than combustible cigarettes, ENDS use exposes users to dependence-producing nicotine and respiratory and cardiovascular toxicants such as aldehydes. Flavor is a major factor in getting young people to use ENDS, thus limiting flavors to menthol and tobacco for prefilled cartridge ENDS "pod mods" was the first major action taken by the FDA to reduce the spread of ENDS among young people. Menthol flavor, however, can present a potential risk given its increasing popularity among young people in the US, and its puffing and nicotine-enhancing properties. Yet, the extent of menthol's ability to affect users' experience and puffing patterns, and how these affect dependence, exposure to toxicants, and clinical outcomes continue to be understudied. Such evidence will be critical to the FDA's ability to set further regulatory standards to reduce ENDS potential harm. The investigators will conduct a 2x2 (pre-post x menthol vs. tobacco flavor) crossover clinical lab study. The investigator will recruit current/past month ENDS users (n=250, 21-35 yrs), who will attend two sessions and use their ENDS once with menthol and once with tobacco flavors. The proposed studies will answer two key regulatory questions consistent with FDA's focus on the role of flavor in tobacco products' addiction and toxicity; 1) compared to tobacco flavor, does menthol carry additional risk by enhancing puffing, abuse liability, and toxicant exposure in ENDS users, and; 2) is this effect more pronounced among high dependence compared to other users. Other outcomes such as harm perception, satisfaction, clinical responses, intention to use or quit, and group comparisons such as according to race, and sex will allow the FDA a comprehensive assessment of the pros and cons of regulating mentholated ENDS for different segments of the society. Such evidence will help advance FDA regulatory policies with the potential to reduce ENDS harm.
Conditions:
🦠 Electronic Cigarette Use
🗓️ Study Start (Actual)
22 June 2022
🗓️ Primary Completion (Estimated)
31 March 2027
✅ Study Completion (Estimated)
31 March 2027
👥 Enrollment (Estimated)
250
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Miami, Florida, United States
Description
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.
Ages Eligible for Study:
21 Years to 35 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Yes
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
4 April 2022
- First Submitted that Met QC Criteria
20 April 2022
- First Posted
21 April 2022
Study Record Updates
- Last Update Submitted that Met QC Criteria
28 February 2024
- Last Update Posted
29 February 2024
- Last Verified
February 2024