Electronic Cigarette UseNCT05338801
Effect of Menthol on ENDS Users' Addiction and Exposure
A study testing Menthol-flavored e-cigarette and Tobacco-flavored e-cigarette in people with Electronic Cigarette Use, run by Florida International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use
- What is being tested?
- Menthol-flavored e-cigarette and Tobacco-flavored e-cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2022to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida International University
Miami, Florida, 33199
Katherine Pita, BSN, RN, 305-348-1691, kmpita@fiu.edu
Wasim Maziak, MD,PhD
About this study
Official title: The Effect of Menthol on ENDS Users' Dependence, Respiratory, and Toxicants Emission Outcomes.
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.
Read the detailed description
The use of electronic nicotine delivery systems (ENDS; e-cigarettes) has reached epidemic levels among young people in the US. While estimates vary, ENDS have become the leading tobacco product used by young people in this country. 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 other respiratory and cardiovascular toxicants such as aldehydes.
ENDS appealing design, flavors, and marketing on social media have gained them increased popularity among young people in the US. Flavor, especially, is a major driver of ENDS use among young people, thus limiting flavors for prefilled cartridge ENDS "pod mods" to menthol and tobacco was the first major action taken by the FDA to reduce the spread of ENDS. More recently, the FDA announced its commitment to banning mentholated cigarettes and cigars. Menthol ENDS, however, continue to pose a potential risk due to their increasing popularity among young people, and menthol's known initiation- and dependence-enhancing properties. Specifically, menthol can potentiate 1) inhalation by reducing irritation and allowing deeper puffs and aerosol deposition, and 2) the effect of nicotine by altering nicotinic acetylcholine receptors and increasing nicotine's bioavailability. Mentholated tobacco products, moreover, tend to affect minorities, youth, and women disproportionately. Yet, the extent of menthol's ability to alter ENDS use experience and puffing patterns, and how these affect dependence, clinical, and toxicant emissions outcomes in different users continue to be understudied.
Our team of experts in tobacco regulatory science will conduct a 2×2 (pre-post × menthol vs. tobacco flavor) crossover clinical lab study. The investigators will recruit current (past month) closed system ENDS users (n=250, 21-35 yrs, use pod-mods, or disposable ENDS), who will come to the lab for two use sessions once with menthol, and once with tobacco flavored ENDS. While the investigators apply standard lab models suitable for regulatory science, the investigators supplement them with cutting-edge puffing robot technology to explore ENDS-associated toxicant emissions (e.g., aldehydes) in the two flavor conditions. The proposed studies will answer two key regulatory-driven hypotheses consistent with this RFA'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, respiratory symptoms and function, intention to quit or use in the future, and group comparisons according to race, and sex will provide FDA with a comprehensive assessment of the pros and cons of regulating mentholated ENDS for different users. the investigators will test these hypotheses by assessing compared to tobacco-flavored ENDS:
Aim 1. The effects of menthol flavor on subjective, puffing, and respiratory outcomes.
Aim 2. The effects of menthol flavor on ENDS toxicant emissions.
- Conditions
- Electronic Cigarette Use
- Being tested
- Menthol-flavored e-cigarette, Tobacco-flavored e-cigarette
- Keywords
- Menthol Flavor, Tobacco Flavor
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol-flavored e-cigaretteOther
All participants will complete a lab visit where they will use menthol-flavored e-cigarette ad libitum for up to 60 minutes.
Tobacco-flavored e-cigaretteOther
All participants will complete a lab visit where they will use tobacco-flavored e-cigarette ad libitum for up to 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Tobacco-flavored e-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma nicotine
Change in plasma nicotine level
Measured: 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
This scale is used to assess the extent to which product use reduces tobacco abstinence. symptoms, and consists of 11 items scored 0 - 100. These items are presented as Visual Analog Scale with item (measure) centered above a horizontal line anchored on the left with not at all and on the right with extremely.
Measured: 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
This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 10 items that are scored 0 - 7. Rated on a 7-point Likert scale ranging from 0 (strongly disagree) to 6 (strongly agree).
Measured: 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
Change in carbon monoxide levels (in parts per million).
Measured: 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
This scale will assess harm perception and measure perceptions of e-cigarette. relative risk compared to cigarettes. The scale will be scored on a 7-point scale ranging from 1 (not at all harmful), to 7 (extremely harmful).
Measured: 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
This scale will assess participants sensory experience of the inhaled product. The scale has nine items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).
Measured: 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
The Cigarette/ENDS Evaluation Scale (WES)
This scale assesses participants' perception of ENDS use. The scale has 11 items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).
Measured: 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
Forced expiratory volume (FEV1)
Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath.FEV is used to measure lung function.
Measured: During participants' 2 study visits. FEV tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Forced vital capacity (FVC)
Forced vital capacity (FVC) is the maximum amount of air that can be exhaled when blowing out as fast as possible FVC is used to measure lung function.
Measured: During participants' 2 study visits. FVC tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Peak expiratory flow (PEF)
Peak expiratory flow (PEF) is the maximal flow that can be exhaled when blowing out at a steady rate. PEF is used to measure lung function.
Measured: During participants' 2 study visits. PEF tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Forced expiratory flow
Forced expiratory flow, also known as mid-expiratory flow; the rates at 25%, 50% and 75% FVC are given. Forced expiratory flowis used to measure lung function.
Measured: During participants' 2 study visits. Forced expiratory flow tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Puff number using eTOP topography machine
Using eTOP topography machine, the investigator will assess the number of puffs during the session as part of puffing behaviour assessment.
Measured: During participants' 2 study visits. Puff number is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Puff duration (seconds) using eTOP topography machine
Using eTOP topography machine, the investigator will assess the duration of the puffs (in seconds) during the session as part of puffing behaviour assessment.
Measured: During participants' 2 study visits. Puff duration is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Puff volume (ml) using eTOP topography machine
Using eTOP topography machine, the investigator will assess the volume of the puffs (in ml) during the session as part of puffing behaviour assessment.
Measured: During participants' 2 study visits. Puff volume is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Inter puff interval (IPI) (second) using eTOP topography machine
Using eTOP topography machine, the investigator will assess the inter puff interval (in second) during the session as part of puffing behaviour assessment.
Measured: During participants' 2 study visits. Inter puff interval is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Aldehydes (concentration) using smoking robot
Using a smoking robot that precisely plays back the puff-by-puff behavior of each participant, we will measure concentration of aldehyde emissions during the session.
Measured: During the 2 participant visits. Aldehydes will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start22 Jun 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wasim Maziak, PhD, MD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338801
- Sponsor's protocol ID
- R01DA055937
- Status last verified
- Mar 2026
- First submitted
- 4 Apr 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roy S, Chowdhury S, Ferdous T, Shihadeh A, Salman R, El Hage R, Salam S, Bursac Z, Maziak W. Predicting nicotine emissions and plasma nicotine boost in E-cigarette users using machine learning. Sci Rep. 2026 Jun 13. doi: 10.1038/s41598-026-57341-4. Online ahead of print.
PubMed 42288659Chowdhury 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.
PubMed 40813093
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menthol on ENDS Users' Dependence, Respiratory, and Toxicants Emission Outcomes.
- ClinicalTrials.gov ID
- NCT05338801
- Acronym / sponsor ID
- R01DA055937
- Conditions
- Electronic Cigarette Use
- Keywords
- Menthol Flavor, Tobacco Flavor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The use of electronic nicotine delivery systems (ENDS; e-cigarettes) has reached epidemic levels among young people in the US. While estimates vary, ENDS have become the leading tobacco product used by young people in this country. 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 other respiratory and cardiovascular toxicants such as aldehydes.
ENDS appealing design, flavors, and marketing on social media have gained them increased popularity among young people in the US. Flavor, especially, is a major driver of ENDS use among young people, thus limiting flavors for prefilled cartridge ENDS "pod mods" to menthol and tobacco was the first major action taken by the FDA to reduce the spread of ENDS. More recently, the FDA announced its commitment to banning mentholated cigarettes and cigars. Menthol ENDS, however, continue to pose a potential risk due to their increasing popularity among young people, and menthol's known initiation- and dependence-enhancing properties. Specifically, menthol can potentiate 1) inhalation by reducing irritation and allowing deeper puffs and aerosol deposition, and 2) the effect of nicotine by altering nicotinic acetylcholine receptors and increasing nicotine's bioavailability. Mentholated tobacco products, moreover, tend to affect minorities, youth, and women disproportionately. Yet, the extent of menthol's ability to alter ENDS use experience and puffing patterns, and how these affect dependence, clinical, and toxicant emissions outcomes in different users continue to be understudied.
Our team of experts in tobacco regulatory science will conduct a 2×2 (pre-post × menthol vs. tobacco flavor) crossover clinical lab study. The investigators will recruit current (past month) closed system ENDS users (n=250, 21-35 yrs, use pod-mods, or disposable ENDS), who will come to the lab for two use sessions once with menthol, and once with tobacco flavored ENDS. While the investigators apply standard lab models suitable for regulatory science, the investigators supplement them with cutting-edge puffing robot technology to explore ENDS-associated toxicant emissions (e.g., aldehydes) in the two flavor conditions. The proposed studies will answer two key regulatory-driven hypotheses consistent with this RFA'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, respiratory symptoms and function, intention to quit or use in the future, and group comparisons according to race, and sex will provide FDA with a comprehensive assessment of the pros and cons of regulating mentholated ENDS for different users. the investigators will test these hypotheses by assessing compared to tobacco-flavored ENDS:
Aim 1. The effects of menthol flavor on subjective, puffing, and respiratory outcomes.
Aim 2. The effects of menthol flavor on ENDS toxicant emissions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menthol-flavored e-cigarette | Experimental | Other: Menthol-flavored e-cigaretteAll participants will complete a lab visit where they will use menthol-flavored e-cigarette ad libitum for up to 60 minutes. |
| Tobacco-flavored e-cigarette | Experimental | Other: Tobacco-flavored e-cigaretteAll participants will complete a lab visit where they will use tobacco-flavored e-cigarette ad libitum for up to 60 minutes. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menthol-flavored e-cigaretteAll 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-cigaretteAll 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 |
Primary outcome
Plasma nicotine
Time frame: 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
Change in plasma nicotine level
15 secondary outcomes
Minnesota Nicotine Withdrawal Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
The Cigarette/ENDS Evaluation Scale (WES)
Time frame: 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
Forced expiratory volume (FEV1)
Time frame: During participants' 2 study visits. FEV tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Forced vital capacity (FVC)
Time frame: During participants' 2 study visits. FVC tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Peak expiratory flow (PEF)
Time frame: During participants' 2 study visits. PEF tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Forced expiratory flow
Time frame: During participants' 2 study visits. Forced expiratory flow tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Puff number using eTOP topography machine
Time frame: During participants' 2 study visits. Puff number is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Puff duration (seconds) using eTOP topography machine
Time frame: During participants' 2 study visits. Puff duration is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Puff volume (ml) using eTOP topography machine
Time frame: During participants' 2 study visits. Puff volume is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Inter puff interval (IPI) (second) using eTOP topography machine
Time frame: During participants' 2 study visits. Inter puff interval is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Aldehydes (concentration) using smoking robot
Time frame: During the 2 participant visits. Aldehydes will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 42288659Roy S, Chowdhury S, Ferdous T, Shihadeh A, Salman R, El Hage R, Salam S, Bursac Z, Maziak W. Predicting nicotine emissions and plasma nicotine boost in E-cigarette users using machine learning. Sci Rep. 2026 Jun 13. doi: 10.1038/s41598-026-57341-4. Online ahead of print.
- Derived from this study: PubMed 40813093Chowdhury 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wasim Maziak, PhD, MD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menthol-flavored e-cigarette and Tobacco-flavored e-cigarette in people with Electronic Cigarette Use, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wasim Maziak, PhD, MD (3053484501, wmaziak@fiu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma nicotine (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05338801, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.