Effect of Menthol on ENDS Users' Addiction and Exposure

NCT05338801 | Recruiting

• 1 other identifier: R01DA055937
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Menthol Flavor; Tobacco Flavor

Outcome Measures

Primary Outcomes (1)

• Plasma nicotine

  Change in plasma nicotine level

  During the 2 participant visits. Blood will be taken 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period

Secondary Outcomes (15)

• Minnesota Nicotine Withdrawal Scale

  During participants' 2 study visits. Questionnaire will be administered 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period

• Tiffany-Drobes Questionnaire of Smoking Urges

  During participants' 2 study visits. Questionnaire will be administered 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period

• Carbon monoxide levels

  During participants' 2 study visits. Carbon monoxide levels will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period

• Harm perception

  During participants' 2 study visits. Questionnaire will be administered after each of the 2 e-cigarette use sessions. Each session is approximately 60 minutes ad lib use period

• Duke Sensory Questionnaire

  During participants' 2 study visits. Questionnaire will be administered after each of the 2 e-cigarette use sessions. Each session is approximately 60 minutes ad lib use period

Other Outcomes (3)

• Heart rate

  During participants' 2 study visits. Heat rate will be measured from baseline continuously throughout each approximately 60 minutes session

• Systolic blood pressure

  During participants' 2 study visits. Systolic blood pressure will be measured from baseline continuously throughout each approximately 60 minutes session

• Diastolic blood pressure

  During participants' 2 study visits. Diastolic blood pressure will be measured from baseline continuously throughout each approximately 60 minutes session

Study Arms (2)

Menthol-flavored e-cigarette

EXPERIMENTAL

All participants will complete a lab visit where they will use menthol-flavored e-cigarette ad libitum for up to 60 minutes.

Other: Menthol-flavored e-cigarette

Tobacco-flavored e-cigarette

EXPERIMENTAL

All participants will complete a lab visit where they will use tobacco-flavored e-cigarette ad libitum for up to 60 minutes.

Other: Tobacco-flavored e-cigarette

Interventions

Menthol-flavored e-cigarette OTHER

All participants will complete a lab visit where they will use menthol-flavored e-cigarette ad libitum for up to 60 minutes.

Menthol-flavored e-cigarette

Tobacco-flavored e-cigarette OTHER

All participants will complete a lab visit where they will use tobacco-flavored e-cigarette ad libitum for up to 60 minutes.

Tobacco-flavored e-cigarette

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

RECRUITING

Related Publications (1)

• Chowdhury S, Roy S, Ferdous T, Osibogun O, Asfar T, Bursac Z, Maziak W. Menthol flavour enhances vaping experiences: a randomised crossover clinical trial. Tob Control. 2025 Aug 14:tc-2024-059202. doi: 10.1136/tc-2024-059202. Online ahead of print.

  PMID: 40813093 DERIVED

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Wasim Maziak, PhD, MD

  Florida International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wasim Maziak, PhD, MD

CONTACT

3053484501; wmaziak@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to study condition
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 21, 2022
• Study Start: June 22, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)