Menthol-Flavored E-Cigarettes for Vaping

Overseen By Wasim Maziak, PhD, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Must not be taking: Prescription medications

Disqualifiers: Chronic disease, Cardiovascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 sessions

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how menthol-flavored e-cigarettes affect users compared to tobacco-flavored ones. Researchers seek to determine if menthol increases vaping frequency, addiction levels, or exposure to harmful substances. Participants will use both menthol and tobacco-flavored e-cigarettes in a lab setting to compare the effects. The trial seeks current e-cigarette users who have vaped in the past month and can abstain from vaping 12 hours before each session. Findings could assist the FDA in deciding on future regulations for e-cigarette flavors. As an unphased trial, this study offers participants a chance to contribute to important research that could shape future e-cigarette regulations.

Will I have to stop taking my current medications?

The trial excludes individuals who regularly use prescription medications (other than vitamins or birth control), so you may need to stop taking your current medications to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that menthol-flavored e-cigarettes might pose some risks. Studies have found that menthol can lead to lung issues, such as reduced lung function and possible lung damage. This flavor can increase the number of inhaled particles, potentially harming the lungs.

For tobacco-flavored e-cigarettes, the FDA has approved some products, indicating they have been checked for safety. However, little evidence exists about how tobacco flavor directly affects health. In general, e-cigarettes expose users to potentially harmful chemicals.

Overall, both menthol and tobacco flavors are available, but they come with potential risks. It's important to consider these risks before deciding to use them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the menthol-flavored and tobacco-flavored e-cigarettes in this trial because they offer a unique way to explore vaping behaviors and preferences. Unlike traditional smoking cessation methods that focus on nicotine replacement or behavioral therapy, these e-cigarettes allow researchers to assess the impact of flavor on vaping habits directly. Menthol and tobacco flavors could offer insights into how taste influences user satisfaction and potentially helps reduce cigarette use by providing a more appealing alternative. This trial could pave the way for more personalized and effective smoking cessation strategies.

What evidence suggests that this trial's treatments could be effective for reducing ENDS harm?

This trial will compare menthol-flavored e-cigarettes with tobacco-flavored e-cigarettes. Research has shown that menthol-flavored e-cigarettes might make vaping more enjoyable. Users often report a preference for menthol over tobacco flavor. However, menthol can harm lung function over time by increasing the number of particles inhaled. In contrast, tobacco-flavored e-cigarettes seem to have a smaller effect on vaping habits and nicotine consumption. Studies suggest that while flavors like menthol can enhance vaping enjoyment, they may also raise health risks. Both flavors affect nicotine exposure and user behavior differently, which is important for potential trial participants to consider. ^{4 6 7 8 9}

Who Is on the Research Team?

Wasim Maziak, PhD, MD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 21-35 who use e-cigarettes at least occasionally in the past month. Participants must not be pregnant, breastfeeding, or using other tobacco products regularly. They should have no chronic diseases, psychiatric conditions, cardiovascular issues, or regular medication use (except vitamins/birth control).

Inclusion Criteria

Generally healthy individuals (determined by physical examination)

Generally healthy individuals (determined by physical examination).

You have used e-cigarettes at least once in the past 30 days.

Exclusion Criteria

I am currently experiencing symptoms like cough, fever, or chest pain.

I am not pregnant or breastfeeding.

You have a long-term health condition or mental health condition that you have previously reported.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend two lab sessions to use menthol and tobacco-flavored e-cigarettes for up to 60 minutes each

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for changes in nicotine levels, respiratory function, and other clinical outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Menthol-flavored e-cigarette
• Tobacco-flavored e-cigarette

Trial Overview The study examines if menthol flavor in e-cigarettes affects addiction and exposure to toxicants more than tobacco flavor. It's a crossover study where participants will try both flavors during separate sessions and researchers will measure their puffing patterns and clinical responses.

How Is the Trial Designed?

Group I: Tobacco-flavored e-cigarette Experimental Treatment 1 Intervention

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

Group II: Menthol-flavored e-cigarette Experimental Treatment 1 Intervention

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 is already approved in United States, European Union, Canada, Japan, China for the following indications:

Approved in United States as Menthol e-liquid for:

• None (regulated as a tobacco product)

Approved in European Union as Menthol e-liquid for:

• None (regulated as a tobacco product)

Approved in Canada as Menthol e-liquid for:

• None (regulated as a tobacco product)

Approved in Japan as Menthol e-liquid for:

• None (regulated as a tobacco product)

Approved in China as Menthol e-liquid for:

• None (regulated as a tobacco product)

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Published Research Related to This Trial

Exclusive menthol cigarette use is significantly higher among non-Hispanic Black individuals and low-income adults compared to non-Hispanic White and high-income groups, indicating potential disparities in tobacco product preferences.

Younger adults are more likely to use sweet/spicy flavored e-cigarettes and combine different flavors with menthol cigarettes, suggesting that regulations targeting menthol cigarettes may need to include restrictions on appealing e-cigarette flavors to effectively reduce usage among this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flavoring Patterns of Exclusive and Dual-Use of Cigarettes and E-Cigarettes Among US Adults: Results from the TUS-CPS 2018-2019. Zavala-Arciniega, L., Hirschtick, JL., Meza, R., et al.[2023]

Menthol smokers using JUUL were more likely to switch from cigarettes to vaping compared to nonmenthol smokers, with 42.6% of menthol smokers switching versus 38.8% of nonmenthol smokers, indicating a potential advantage of ENDS for this group.

A significant preference for Menthol/Mint-flavored JUULpods was observed among menthol smokers (53.8%) compared to nonmenthol smokers (22.9%), suggesting that offering menthol-flavored ENDS could enhance switching rates among menthol smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in switching away from cigarettes and JUUL use characteristics among adult menthol and nonmenthol smokers who purchased the JUUL System. Goldenson, NI., Augustson, EM., Shiffman, S.[2022]

In a study of 64 black and Latinx menthol cigarette smokers, both menthol and non-menthol e-cigarettes showed similar high rates of switching and acceptability, indicating that restricting menthol e-liquids may not negatively impact these smokers' transition to e-cigarettes.

Participants using menthol e-cigarettes reported comparable reductions in daily cigarette consumption and similar subjective effects to those using non-menthol e-cigarettes, suggesting that both types of e-cigarettes are effective alternatives for menthol smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menthol versus non-menthol flavouring and switching to e-cigarettes in black and Latinx adult menthol combustible cigarette smokers: secondary analyses from a randomised clinical trial. Nollen, NL., Leavens, ELS., Ahluwalia, JS., et al.[2023]

From January 2017 to November 2021, sales of cooling flavoured e-cigarettes in the USA surged by 693%, indicating a growing popularity among consumers, particularly youth.

The proportion of non-menthol cooling disposable e-cigarettes skyrocketed, highlighting a shift in consumer preference away from traditional menthol flavours, which could impact future regulatory strategies for flavoured e-cigarette use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in unit sales of cooling flavoured e-cigarettes, USA, 2017-2021. Ali, FRM., Seaman, EL., Diaz, MC., et al.[2022]

In a survey of 4,875 high school students, over half (51.6%) reported using e-cigarettes with cooling flavors, indicating a significant trend among youth.

The use of cooling flavors was linked to more frequent vaping and a higher likelihood of using nicotine, suggesting that these flavors may enhance the appeal and usage of e-cigarettes among young users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cooling e-cigarette flavors and the association with e-cigarette use among a sample of high school students. Davis, DR., Morean, ME., Bold, KW., et al.[2023]

A study of 38 vape shop websites in the Greater Los Angeles Area identified 1330 e-liquid flavors, with 219 categorized as menthol, mint, or ice flavors, indicating a significant presence of cooling flavors in the market.

The majority of these cooling flavors (70.3% of ice flavors and 63.3% of menthol flavors) were marketed in combination with fruit, suggesting a trend towards appealing flavor profiles that may attract a wide range of consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A content analysis of website marketing for cooling flavored e-liquids in a sample of brick-and-mortar vape shops in the Greater Los Angeles area. Brown, N., Shin, H., Whooley, S., et al.[2022]

Synthetic cooling agents WS-3 and WS-23 were found in a majority of US-marketed E-cigarettes, including popular brands like Puffbar, indicating widespread use beyond just menthol-flavored products.

The levels of these synthetic coolants may pose health risks, as the margin of exposure (MOE) calculations showed values below the safety threshold of 100 for most daily use scenarios, suggesting potential consumer exposure exceeding safety limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthetic Cooling Agents in US-marketed E-cigarette Refill Liquids and Popular Disposable E-cigarettes: Chemical Analysis and Risk Assessment. Jabba, SV., Erythropel, HC., Torres, DG., et al.[2023]

A study analyzing over 14,000 e-liquid products from five online vape shops found that fruit flavors were the most popular, followed by dessert and candy flavors, indicating a strong preference among youth users for sweet and fruity options.

The findings suggest that many e-liquids are marketed with multiple flavor profiles, which may complicate regulatory efforts by the FDA to restrict certain flavors, highlighting the need for further investigation into compliance with flavor restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding the E-Liquid Flavor Wheel: Classification of Emerging E-Liquid Flavors in Online Vape Shops. Ma, S., Qiu, Z., Yang, Q., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S030646032400087X

Menthol versus tobacco e-liquid flavor: Impact on acute ... Among menthol smokers in a lab-based setting, findings suggest that menthol vs tobacco e-liquid flavor has little impact on acute changes in puff patterns, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12477640/

Menthol Flavor Enhances Vaping Experiences Participants reported better experience (satisfaction, psychological reward, enjoyment of respiratory tract sensations, and craving reduction) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05338801

Effect of Menthol on ENDS Users' Addiction and Exposure | ... While generally considered less harmful than combustible cigarettes, ENDS use exposes users to dependence-producing nicotine and respiratory and cardiovascular ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8960730/

Menthol Flavor in E-Cigarette Vapor Modulates Social ... Our data suggested that long exposure to menthol-flavored ENDS may have compensatory enhancing effects on the sociability and preference for ...

5. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-023-02410-9

Electronic cigarette menthol flavoring is associated with ... Our results reveal an association between enhanced inhaled particle due to menthol addition to ECs and worse lung function indices.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10026991/

Menthol flavoring in e-cigarette condensate causes ... These data demonstrate prominent menthol-induced pulmonary toxicity and impairment of essential physiological functions in the lung.

7. fda.gov fda.gov/tobacco-products/products-ingredients-components/e-cigarettes-vapes-and-other-electronic-nicotine-delivery-systems-ends

E-Cigarettes, Vapes, and other Electronic Nicotine Delivery ... To date, FDA has authorized 39 tobacco- and menthol-flavored e-cigarette products and devices. These products have undergone rigorous ...

8. vapekit.co.uk vapekit.co.uk/downloads/1622107687ALL_VAPE_-_CLUB_JUICE_SALT_-_MENTHOL_20MG.pdf

SAFETY DATA SHEET This product is toxic if swallowed, causes skin and eye irritation, may cause allergic skin reaction, and is harmful if inhaled. Keep out of reach of children.

9. upmc.com upmc.com/media/news/041123-vape-juice-toxic-to-lungs

Menthol Flavor Makes Vape Juice More Toxic, Damaging ... Scientists used a vaping robot to test if menthol flavoring changes the number of inhaled vapor particles and affects lung health.