E-liquid Coolants for Nicotine Addiction

Overseen ByWei Li, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

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

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

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.