E-liquid Coolants for Nicotine Addiction

Overseen By Wei Li, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Medical condition, Hypersensitivity, Pregnant, Asthma, Allergy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 sessions

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different cooling additives, such as menthol, affect the appeal and addiction potential of nicotine e-liquids. Researchers aim to determine if these e-liquid coolants increase the attractiveness or addictiveness of e-cigarettes. Participants will try e-liquids with varying menthol levels to identify which combinations might be most appealing. Suitable candidates for this trial are adults who currently use e-cigarettes and are comfortable with menthol flavors. As an unphased trial, this study allows participants to contribute to important research on e-cigarette appeal and addiction.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does require you to abstain from tobacco or nicotine use for 2 hours before sessions.

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

Previous studies have shown potential risks to lung health from menthol flavoring in e-cigarettes. Research indicates that menthol can harm the lungs and disrupt their normal functions, regardless of whether menthol levels in e-cigarette liquids are high or low. Additionally, using e-cigarettes has been linked to various health risks, including exposure to harmful substances that may damage the lungs and other organs.

For non-menthol e-cigarette liquids, studies have identified various substances that could also pose risks, such as nicotine and other chemicals that might affect health. Synthetic cooling agents like WS-3 and WS-23, used in non-menthol liquids, can reduce nicotine harshness, potentially making e-liquids more appealing but also raising safety concerns.

Overall, while researchers study these treatments, known risks are associated with e-liquid ingredients. Participants should consider these findings when deciding whether to join trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these e-liquid coolants for nicotine addiction because they explore the role of menthol concentration in aiding smoking cessation. Unlike traditional nicotine replacement therapies such as patches, gums, or lozenges, these treatments incorporate varying levels of menthol, which may enhance the sensory experience and potentially increase satisfaction for users trying to quit smoking. By adjusting menthol levels while maintaining a consistent nicotine dose, these new e-liquids might provide a more tailored approach to managing cravings and withdrawal symptoms. This novel method could offer a more engaging alternative for individuals seeking to quit smoking, potentially increasing success rates.

What evidence suggests that this trial's treatments could be effective for nicotine addiction?

This trial will evaluate various e-liquid formulations with different menthol concentrations and nicotine levels to understand their impact on nicotine addiction. Research has shown that menthol in e-liquids creates a cooling sensation, making them more appealing and possibly more addictive. Menthol can make smoking feel smoother, allowing for deeper breaths. Some studies suggest that people who smoke menthol cigarettes find it harder to quit, although this can vary. For e-liquids with low menthol, vaping can help reduce the urge to smoke after a break from tobacco. In contrast, non-menthol e-liquids have been linked to higher success rates in quitting smoking, with different flavors also aiding cessation. Overall, the effectiveness of these e-liquids can depend on personal preferences and the amount of menthol. Participants in this trial will be assigned to different arms to test these variations. ^{6 7 8 9 10}

Who Is on the Research Team?

Suchitra Krishnan-Sarin, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults who can read and write, currently use e-cigarettes to some extent, and are willing to refrain from using tobacco or nicotine for at least 2 hours before the study sessions.

Inclusion Criteria

Able to read and write

Some current e-cigarette use

Willing to abstain from tobacco/nicotine use 2 hrs prior to sessions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 3 laboratory sessions to evaluate the appeal and addiction potential of e-cigarettes with different cooling components

3 sessions

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• E-liquid coolant

Trial Overview The study tests how different cooling agents (WS-3, WS-23) and levels of menthol in e-liquids affect their appeal and potential to increase addiction to nicotine among adult users.

How Is the Trial Designed?

Group I: Non-menthol, nicotine 59mg/ml (5) Experimental Treatment 1 Intervention

Flavor without menthol with 59mg/ml nicotine

Group II: Non-menthol, nicotine 59mg/ml (4) Experimental Treatment 1 Intervention

Flavor without menthol with 59mg/ml nicotine

Group III: Non-menthol, nicotine 59mg/ml (3) Experimental Treatment 1 Intervention

Flavor without menthol with 59mg/ml nicotine

Group IV: Non-menthol, nicotine 59mg/ml (2) Experimental Treatment 1 Intervention

Flavor without menthol with 59mg/ml nicotine

Group V: Non-menthol, nicotine 59mg/ml (1) Experimental Treatment 1 Intervention

Flavor without menthol with 59mg/ml nicotine

Group VI: Low menthol, nicotine 59mg/ml (5) Experimental Treatment 1 Intervention

Flavor low menthol concentration with 59mg/ml nicotine

Group VII: Low menthol, nicotine 59mg/ml (4) Experimental Treatment 1 Intervention

Flavor low menthol concentration with 59mg/ml nicotine

Group VIII: Low menthol, nicotine 59mg/ml (3) Experimental Treatment 1 Intervention

Flavor with low menthol concentration with 59mg/ml nicotine

Group IX: Low menthol, nicotine 59mg/ml (2) Experimental Treatment 1 Intervention

Flavor with low menthol concentration with 59mg/ml nicotine

Group X: Low menthol, nicotine 59mg/ml (1) Experimental Treatment 1 Intervention

Flavor with low menthol concentration with 59mg/ml nicotine

Group XI: High menthol, nicotine 59mg/ml (5) Experimental Treatment 1 Intervention

Flavor high menthol concentration with 59mg/ml nicotine

Group XII: High menthol, nicotine 59mg/ml (4) Experimental Treatment 1 Intervention

Flavor high menthol concentration with 59mg/ml nicotine

Group XIII: High menthol, nicotine 59mg/ml (3) Experimental Treatment 1 Intervention

Flavor with high menthol concentration with 59mg/ml nicotine

Group XIV: High menthol, nicotine 59mg/ml (2) Experimental Treatment 1 Intervention

Flavor with high menthol concentration with 59mg/ml nicotine

Group XV: High menthol, nicotine 59mg/ml (1) Experimental Treatment 1 Intervention

Flavor with high menthol concentration with 59mg/ml nicotine

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8248945/

The Relationship Between Menthol Cigarette Use ... In comparative effectiveness trials of cessation treatments, some studies find that menthol cigarette smokers are less likely to successfully quit as compared ...

2. kucancercenter.org kucancercenter.org/news-room/news/2022/04/study-to-gauge-effectiveness-of-menthol-e-cigarettes-as-a-quit-smoking-tool

Study to gauge effectiveness of menthol e-cigarettes as a ... Menthol cigarettes are higher in nicotine and more addictive. The cooling sensation of menthol allows smokers to inhale more deeply. This may be ...

3. truthinitiative.org truthinitiative.org/sites/default/files/media/files/2024/01/Menthol%20Fact%20Sheet%20Updated%201.23.24.pdf

The chemical compound menthol makes cigarettes easier ... The chemical compound menthol makes cigarettes easier to smoke and harder to quit. Menthol creates a cooling effect, reduces the harshness ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7161928/

Use of Mentholated Cigarettes and Likelihood of Smoking ... Some studies show that menthol smokers are less likely to quit smoking,15–17 whereas others find no difference.

5. tobaccopreventioncessation.com tobaccopreventioncessation.com/pdf-196136-120344?filename=120344.pdf

E-liquid flavors and nicotine concentration choices over 6 ... Overall, our study suggests that smokers willing to quit smoking with the help of ENDS may start with e-liquids that contain a high ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6018193/

E-cigarettes: Impact of E-liquid Components and Device ... This review focuses on factors which may impact nicotine exposure by changing e-cigarette use behavior, puff topography, altering the nicotine yield.

8. newsroom.heart.org newsroom.heart.org/news/current-evidence-identifies-health-risks-of-e-cigarette-use-long-term-research-needed

Current evidence identifies health risks of e-cigarette use Given the established, high health risks of smoking combustible cigarettes, e-cigarette products have been evaluated as smoking cessation tools.

9. mdpi.com mdpi.com/2305-6304/13/4/268

A Comprehensive Review of the Harmful Compounds in ... Regarding health, vape liquids contain potentially toxic compounds that may damage the lungs and other organs. Furthermore, the long-term effects of vapor ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2214750022001949

E-cigarette synthetic cooling agent WS-23 and nicotine ... However, recent studies have found that e-cig/ENDS use during smoking cessation led to both a reduced effectiveness in cessation and a higher relapse rate as ...