30 Participants Needed

Cooling Flavors for Electronic Cigarette Use

DD
WL
Overseen ByWEI Li, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This pilot sensory experiment will examine cooling from comparable concentrations of WS-3 and menthol to determine appropriate concentrations to use in the main study.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is it safe to use cooling flavors in e-cigarettes?

Research indicates that while some cooling agents like menthol and WS-23 are used in e-cigarettes, their safety when inhaled is not well understood. High concentrations of flavor chemicals, including menthol, can be harmful, and the potential health risks from inhaling these substances need further study.12345

What makes this e-liquid coolant treatment unique compared to other treatments?

This e-liquid coolant treatment is unique because it uses different concentrations of menthol and other cooling agents (WS-23 and WS-3) to provide a cooling sensation, which may enhance the vaping experience. Unlike traditional treatments, this approach focuses on the sensory effects of vaping rather than addressing a medical condition.678910

Research Team

SK

Suchitra Krishnan-Sarin, PhD

Principal Investigator

Yale University

Eligibility Criteria

Adults who have used nicotine e-cigarettes, can read and write, and have vaped in the past month. Not for those allergic to propylene glycol or nut/e-liquid flavors, pregnant or breastfeeding women, people with uncontrolled asthma, marijuana vapers, or anyone showing symptoms of lung injury from vaping.

Inclusion Criteria

Used e-cigarettes containing nicotine
Able to read and write
Use e-cigs in past 30 days

Exclusion Criteria

Known hypersensitivity to propylene glycol
My asthma is not well-managed.
Pregnant or lactating females
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants are exposed to e-liquids containing five different concentrations of two different cooling flavors without nicotine and rate 'coolness' using the generalized Labeled Magnitude Scale (gLMS)

1 day
1 visit (in-person)

Follow-up

Participants are monitored for any adverse reactions and effectiveness of the cooling sensation

1 week

Treatment Details

Interventions

  • E-liquid coolant (menthol, 0.05%)
  • E-liquid coolant (menthol, 0.1%)
  • E-liquid coolant (menthol, 0.5%)
  • E-liquid coolant (menthol, 1.0%)
  • E-liquid coolant (menthol, 2.0%)
  • E-liquid coolant (WS-23, 0.05%)
  • E-liquid coolant (WS-23, 0.1%)
  • E-liquid coolant (WS-23, 0.5%)
  • E-liquid coolant (WS-23, 1.0%)
  • E-liquid coolant (WS-23, 2.0%)
  • E-liquid coolant (WS-23, 4.0%)
  • E-liquid coolant (WS-3, 0.05%)
  • E-liquid coolant (WS-3, 0.1%)
  • E-liquid coolant (WS-3, 0.5%)
  • E-liquid coolant (WS-3, 1.0%)
  • E-liquid coolant (WS-3, 2.0%)
Trial Overview The trial is testing how different concentrations of cooling agents (WS-23 and WS-3) and menthol affect the sensory experience when using e-cigarettes. It's a preliminary study to decide on concentrations for future research.
Participant Groups
16Treatment groups
Experimental Treatment
Group I: WS-3 (5), no nicotineExperimental Treatment1 Intervention
WS-3 block: 2.0%
Group II: WS-3 (4), no nicotineExperimental Treatment1 Intervention
WS-3 block: 1.0%
Group III: WS-3 (3), no nicotineExperimental Treatment1 Intervention
WS-3 block: 0.5%
Group IV: WS-3 (2), no nicotineExperimental Treatment1 Intervention
WS-3 block: 0.1%
Group V: WS-3 (1), no nicotineExperimental Treatment2 Interventions
WS-3 block: 0.05%
Group VI: WS-23 (6), no nicotineExperimental Treatment1 Intervention
WS-23 block: 4.0%
Group VII: WS-23 (5), no nicotineExperimental Treatment1 Intervention
WS-23 block: 2.0%
Group VIII: WS-23 (4), no nicotineExperimental Treatment1 Intervention
WS-23 block: 1.0%
Group IX: WS-23 (3), no nicotineExperimental Treatment1 Intervention
WS-23 block: 0.5%
Group X: WS-23 (2), no nicotineExperimental Treatment1 Intervention
WS-23 block: 0.1%
Group XI: WS-23 (1), no nicotineExperimental Treatment1 Intervention
WS-23 block: 0.05%
Group XII: Menthol (5), no nicotineExperimental Treatment1 Intervention
Menthol block: 2.0%
Group XIII: Menthol (4), no nicotineExperimental Treatment1 Intervention
Menthol block: 1.0%
Group XIV: Menthol (3), no nicotineExperimental Treatment1 Intervention
Menthol block: 0.5%
Group XV: Menthol (2), no nicotineExperimental Treatment1 Intervention
Menthol block: 0.1%
Group XVI: Menthol (1), no nicotineExperimental Treatment2 Interventions
Menthol block: 0.05%

E-liquid coolant (menthol, 0.05%) is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Menthol for:
  • General use as a flavoring agent in food and tobacco products
🇺🇸
Approved in United States as Menthol for:
  • General use as a flavoring agent in food and tobacco products

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

The synthetic coolant menthone 1,2-glycerol ketal (MGK) was found in a menthol-flavored e-liquid at a concentration of approximately 170 μg/mL, raising concerns about its potential toxicological risks when inhaled through electronic nicotine delivery systems (ENDS).
The study highlights the need for further research on the inhalation toxicity of MGK in e-liquids, as well as demonstrates a reliable method for quantifying synthetic coolants in these products using liquid chromatography-tandem mass spectrometry.
Detection of the Synthetic Coolant Menthone 1,2-Glycerol Ketal in an e-Liquid and in Electronic Waterpipe Aerosols Therefrom.Klupinski, TP., Strozier, ED., Koebel, DD., et al.[2023]
The study identified 12 flavor chemicals in commercial e-cigarette refill fluids, with over 50% containing high concentrations that can transfer efficiently into aerosols, potentially leading to cytotoxic effects.
Aerosols produced at a higher voltage (5V) were found to be generally more toxic to human lung cells compared to those produced at a lower voltage (3V), highlighting a significant health concern regarding the use of flavored e-cigarettes.
Analytical and toxicological evaluation of flavor chemicals in electronic cigarette refill fluids.Behar, RZ., Luo, W., McWhirter, KJ., et al.[2022]
E-cigarettes with ice-hybrid flavors and synthetic cooling agents like WS-3 and WS-23 have been developed since 1974, but their inhalational toxicology and long-term health effects are still unknown, highlighting a need for further research and regulatory scrutiny.
These products are popular among adolescents and young adults, potentially leading to increased vaping frequency and nicotine dependence, which raises concerns about their impact on public health and the effectiveness of tobacco control measures.
Ice flavours and non-menthol synthetic cooling agents in e-cigarette products: a review.Leventhal, AM., Tackett, AP., Whitted, L., et al.[2023]

References

Detection of the Synthetic Coolant Menthone 1,2-Glycerol Ketal in an e-Liquid and in Electronic Waterpipe Aerosols Therefrom. [2023]
Analytical and toxicological evaluation of flavor chemicals in electronic cigarette refill fluids. [2022]
Ice flavours and non-menthol synthetic cooling agents in e-cigarette products: a review. [2023]
High concentrations of flavor chemicals are present in electronic cigarette refill fluids. [2023]
Carbonyl Composition and Electrophilicity in Vaping Emissions of Flavored and Unflavored E-Liquids. [2021]
Skin Sterility After Application of a Vapocoolant Spray Part 2. [2015]
Comparison of the effects of vapocoolant spray and topical anesthetic cream on pain during needle electromyography in the medial gastrocnemius. [2022]
Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in children. [2013]
Subcutaneous and Intramuscular Hemodynamics and Oxygenation After Cold-Spray Application as Monitored by Near-Infrared Spectroscopy. [2022]
Effects of vapocoolant spray on skin sterility prior to intravenous cannulation. [2015]
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