Tobacco-flavored e-cigarette for Electronic Cigarette Use

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Florida International University, Miami, FL
Electronic Cigarette Use
Tobacco-flavored e-cigarette - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

The use of electronic nicotine delivery systems (ENDS; e-cigarettes) has reached epidemic levels among young people in the United States (US). ENDS heat and vaporize a nicotine-containing liquid to produce an inhalable aerosol mist. While generally considered less harmful than combustible cigarettes, ENDS use exposes users to dependence-producing nicotine and respiratory and cardiovascular toxicants such as aldehydes. Flavor is a major factor in getting young people to use ENDS, thus limiting flavors to menthol and tobacco for prefilled cartridge ENDS "pod mods" was the first major action taken by the FDA to reduce the spread of ENDS among young people. Menthol flavor, however, can present a potential risk given its increasing popularity among young people in the US, and its puffing and nicotine-enhancing properties. Yet, the extent of menthol's ability to affect users' experience and puffing patterns, and how these affect dependence, exposure to toxicants, and clinical outcomes continue to be understudied. Such evidence will be critical to the FDA's ability to set further regulatory standards to reduce ENDS potential harm. The investigators will conduct a 2x2 (pre-post x menthol vs. tobacco flavor) crossover clinical lab study. The investigator will recruit current/past month ENDS users (n=250, 21-35 yrs), who will attend two sessions and use their ENDS once with menthol and once with tobacco flavors. The proposed studies will answer two key regulatory questions consistent with FDA's focus on the role of flavor in tobacco products' addiction and toxicity; 1) compared to tobacco flavor, does menthol carry additional risk by enhancing puffing, abuse liability, and toxicant exposure in ENDS users, and; 2) is this effect more pronounced among high dependence compared to other users. Other outcomes such as harm perception, satisfaction, clinical responses, intention to use or quit, and group comparisons such as according to race, and sex will allow the FDA a comprehensive assessment of the pros and cons of regulating mentholated ENDS for different segments of the society. Such evidence will help advance FDA regulatory policies with the potential to reduce ENDS harm.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: 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

During participants' 2 study visits. Carbon monoxide levels will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Carbon monoxide levels
During participants' 2 study visits. Diastolic blood pressure will be measured from baseline continuously throughout each approximately 60 minutes session
Diastolic blood pressure
During participants' 2 study visits. FEV tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Forced expiratory volume (FEV1)
During participants' 2 study visits. FVC tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Forced vital capacity (FVC)
During participants' 2 study visits. Forced expiratory flow tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Forced expiratory flow
During participants' 2 study visits. Heat rate will be measured from baseline continuously throughout each approximately 60 minutes session
Heart rate
During participants' 2 study visits. Inter puff interval is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Inter puff interval (IPI) (second) using eTOP topography machine
During participants' 2 study visits. PEF tests will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Peak expiratory flow (PEF)
During participants' 2 study visits. Puff duration is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Puff duration (seconds) using eTOP topography machine
During participants' 2 study visits. Puff number is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Puff number using eTOP topography machine
During participants' 2 study visits. Puff volume is continuously measured during each e-cigarette use session (an approximately 60 minutes ad lib use period)
Puff volume (ml) using eTOP topography machine
During participants' 2 study visits. Questionnaire will be administered 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period
Minnesota Nicotine Withdrawal Scale
Tiffany-Drobes Questionnaire of Smoking Urges
During participants' 2 study visits. Questionnaire will be administered after each of the 2 e-cigarette use sessions. Each session is approximately 60 minutes ad lib use period
Duke Sensory Questionnaire
Harm perception
The Cigarette/ENDS Evaluation Scale (WES)
During participants' 2 study visits. Systolic blood pressure will be measured from baseline continuously throughout each approximately 60 minutes session
Systolic blood pressure
During the 2 participant visits. Aldehydes will be measured 2 times in each e-cigarette use session: before and after an approximately 60 minutes ad lib use period]
Aldehydes (concentration) using smoking robot
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
Plasma nicotine

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Menthol-flavored e-cigarette
1 of 2
Tobacco-flavored e-cigarette
1 of 2
Experimental Treatment

250 Total Participants · 2 Treatment Groups

Primary Treatment: Tobacco-flavored e-cigarette · No Placebo Group · Phase 4

Menthol-flavored e-cigarette
Other
Experimental Group · 1 Intervention: Menthol-flavored e-cigarette · Intervention Types: Other
Tobacco-flavored e-cigarette
Other
Experimental Group · 1 Intervention: Tobacco-flavored e-cigarette · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Closest Location: Florida International University · Miami, FL
Photo of Miami 1Photo of Miami 2Photo of Miami 3
2008First Recorded Clinical Trial
4 TrialsResearching Electronic Cigarette Use
21 CompletedClinical Trials

Who is running the clinical trial?

Florida International UniversityLead Sponsor
84 Previous Clinical Trials
14,965 Total Patients Enrolled
3 Trials studying Electronic Cigarette Use
371 Patients Enrolled for Electronic Cigarette Use
Wasim Maziak, PhD, MDPrincipal InvestigatorFlorida International University
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Electronic Cigarette Use
120 Patients Enrolled for Electronic Cigarette Use

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to attend the lab as required by the study protocol.
You are between the ages of 21 and 35 years.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.