Effects of Menthol in E-cigarettes on Smoking Behaviors (NCT04521647) | Clinical Trial Compass
CompletedPhase 1
Effects of Menthol in E-cigarettes on Smoking Behaviors
United States14 participantsStarted 2022-05-10
Plain-language summary
The overall goal of this proposal is to understand the relationship between nicotine metabolism and menthol flavor in e-cigarettes on smoking behavior in smokers.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial specifically studied menthol-flavored e-cigarettes and how they affect nicotine absorption in the blood — given that distinction, would the findings be relevant to my specific smoking habits or the type of products I currently use?
2Since this was a Phase 1 trial focused on measuring plasma nicotine levels and how quickly the body processes nicotine, what does that mean for what we actually know so far about safety and longer-term effects — and are there later-phase studies I should look into?
3The trial is now completed — have the results been published, and if so, what did they show about how menthol changes the way the body absorbs or metabolizes nicotine compared to non-menthol e-cigarettes?
4Given that this study measured nicotine metabolic rate, could my own nicotine metabolism — which can vary between people — affect whether findings from this trial would even apply to me?
5Before considering any e-cigarette-related research as part of my plan, should we talk about whether a standard smoking cessation treatment like nicotine replacement therapy or prescription medication might be a better first step for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma Nicotine Levels
Timeframe: Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure.
2
Nicotine Metabolic Rate
Timeframe: Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure.