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Menthol-Flavored E-Cigarettes for Vaping
N/A
Recruiting
Led By Wasim Maziak, PhD, MD
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age of 21-35 years.
Age of 21-35 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 2 participant visits. blood will be taken 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Awards & highlights
Study Summary
This trial will study the effects of mentholated e-cigarettes compared to tobacco-flavored e-cigarettes in order to help the FDA assess the risks of mentholated e-cigarettes.
Who is the study for?
This trial is for healthy adults aged 21-35 who use e-cigarettes at least occasionally in the past month. Participants must not be pregnant, breastfeeding, or using other tobacco products regularly. They should have no chronic diseases, psychiatric conditions, cardiovascular issues, or regular medication use (except vitamins/birth control).Check my eligibility
What is being tested?
The study examines if menthol flavor in e-cigarettes affects addiction and exposure to toxicants more than tobacco flavor. It's a crossover study where participants will try both flavors during separate sessions and researchers will measure their puffing patterns and clinical responses.See study design
What are the potential side effects?
While specific side effects are not listed for this trial, generally vaping can lead to throat irritation, coughing, dry mouth or eyes, headache and potential nicotine dependence.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 35 years old.
Select...
I am between 21 and 35 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the 2 participant visits. blood will be taken 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 2 participant visits. blood will be taken 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Plasma nicotine
Secondary outcome measures
Aldehydes (concentration) using smoking robot
Carbon monoxide levels
Duke Sensory Questionnaire
+12 moreOther outcome measures
Diastolic blood pressure
Heart rate
Systolic blood pressure
Trial Design
2Treatment groups
Experimental Treatment
Group I: Tobacco-flavored e-cigaretteExperimental Treatment1 Intervention
All participants will complete a lab visit where they will use tobacco-flavored e-cigarette ad libitum for up to 60 minutes.
Group II: Menthol-flavored e-cigaretteExperimental Treatment1 Intervention
All participants will complete a lab visit where they will use menthol-flavored e-cigarette ad libitum for up to 60 minutes.
Find a Location
Who is running the clinical trial?
Florida International UniversityLead Sponsor
99 Previous Clinical Trials
17,055 Total Patients Enrolled
Wasim Maziak, PhD, MDPrincipal InvestigatorFlorida International University
1 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently experiencing symptoms like cough, fever, or chest pain.I am not pregnant or breastfeeding.You have used e-cigarettes at least once in the past 30 days.I am between 21 and 35 years old.You have used e-cigarettes, either every day or once in a while, within the last 30 days.You have a long-term health condition or mental health condition that you have previously reported.I haven't used e-cigarettes in the last 12 hours.I am between 21 and 35 years old.I have used tobacco or nicotine products like e-cigarettes in the last year.You smoke cigarettes regularly, at least 5 cigarettes per month in the past year.You are willing to attend the lab as required by the study protocol.I have a history of heart issues, blood pressure problems, seizures, or I regularly use prescription medication.I have not used e-cigarettes for at least 12 hours before each session.
Research Study Groups:
This trial has the following groups:- Group 1: Menthol-flavored e-cigarette
- Group 2: Tobacco-flavored e-cigarette
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Vaping Patient Testimony for trial: Trial Name: NCT05338801 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is registration open for this investigation?
"Affirmative. According to information available on clinicaltrials.gov, this medical experiment is actively enrolling volunteers. Launched in June 2021 and last updated in July 2021, the study seeks 250 participants from a single site."
Answered by AI
To what extent is enrollment expanding in this experiment?
"Affirmative. The information available on clinicaltrials.gov indicates that this medical trial, which was originally introduced June 1st 2022, is actively scouting for volunteers. A total of 250 participants need to be enrolled from a single medical facility."
Answered by AI
Are individuals aged 30 or above being accepted for enrolment in this research?
"This medical study is only open to individuals aged 21-35. Patients under 18 and above 65 are invited to join 1 or 4 other studies, respectively."
Answered by AI
What risks could be associated with vaping Tobacco-flavored e-juice?
"Because this trial has reached Phase 4, which denotes approval of the treatment, our team assigns a score of 3 to Tobacco-flavored e-cigarette in terms of safety."
Answered by AI
Who can be granted access to this research experiment?
"This clinical trial has a set of inclusion criteria, requiring participants to be between 21 and 35 years old, with the history of electronic cigarette use. Upward of 250 people will have the opportunity to participate in this study."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Florida International University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have done studies in the past and this one interests me.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Email
Phone Call
Most responsive sites:
- Florida International University: < 24 hours
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