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Menthol E-Cigarettes: do they change how you smoke?

NCT ID NCT04521647

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study from Yale University looked at how menthol flavor in e-cigarettes affects smoking behavior and nicotine levels in people who smoke menthol cigarettes. Fourteen adult smokers participated in lab sessions where they used e-cigarettes with menthol or non-menthol flavor. Researchers measured nicotine in the blood to see if menthol changes how much nicotine gets absorbed. The goal was to better understand the link between nicotine metabolism and menthol, which could inform future smoking reduction strategies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nicotine (5%) in e-cigarettes with menthol flavor
What this could lead to
If successful, this could help explain how menthol flavoring influences smoking habits and nicotine intake, potentially guiding future smoking cessation strategies.
What could go wrong
This is a very small, early-phase study with only 14 participants, so results may not apply to the general population. It does not test long-term health effects or quitting success.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

May 2022

Finished

Jul 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * At least 21 years of age * Able to read and write English. * Smoking at least 1 menthol cigarettes/cigars/little cigars per day * Report regular menthol cigarette use * Have at least 200ng/ml urine cotinine * Willing to abstain from combustible tobacco products 12 hrs prior to each experimental session. * not planning a smoking quit attempt. * Have not stopped use due to COVID. * used e-cigarettes at least 10 times in the past six months. * Fully vaccinated against COVID-19. * must report history of JUUL and other nicotine salt/pod devices (i.e., JUUL-like) Exclusion Criteria: * Use of psychoactive drugs including anxiolytics, antidepressants, and other psychostimulants unless prescribed and stable for two months. * Current diagnosis of any severe psychiatric disorder * Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, pulmonary or hepatic pathology that would increase risk or would interfere with/mimic tobacco abstinence. * Known hypersensitivity to propylene glycol and nut allergies. * Pregnant or lactating females. * current criteria for moderate or severe cannabis and alcohol use disorder per DSM-5 criteria. * current criteria for other substance use disorders per DSM-5 criteria. * Seeking treatment to stop smoking. * individuals who do not want to use e-cigarettes. * Uncontrolled asthma (defined as \<20 on Asthma Control Test) AND/OR endorsement of "yes" to environmentally induced bronchospasm that requires prescription Epipen) * blood pressure \>170/\>100 and heart rate \>100 * vaping of CBD/THC or marijuana related products in the past 3 months * For current THC vapers: Any report of mild or great EVALI-related symptoms (i.e. cough, shortness of breath, chest pain, nausea, vomiting, stomach pain, diarrhea, fever, chills, or weight loss) without non-EVALI reasonable and proximal cause

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Connecticut Mental Health Center

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.