ECIG lab session 2 for E Cigarette Use

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
E Cigarette Use
ECIG lab session 2 - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This clinical trial examines the influence of nicotine form, concentration, and e-liquid flavor on youth vaping behavior, as well as the heart and lung effects associated with this behavior. Electronic cigarette (e-cig) "vaping", while being promoted as a safer alternative to conventional cigarettes, has disproportionately attracted adolescents and young adults ("youth"). This trial may help researchers understand how nicotine form, concentration, and flavor affects people's vaping behaviors and health.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 8 Secondary · Reporting Duration: 0, 5, 10, 35 min.

0, 5, 10, 35 min.
Change in plasma nicotine concentration
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form
30 minutes
Vascular reactivity
35 minutes
Airway Inflammation (NIOX VERO)
Average Puff duration
Average Puff volume
Drug Effects/Liking Questionnaire
E-cigarette Purchase Task
Lung function assessment
Puff count
modified Cigarette Evaluation Questionnaire (mCEQ)
Baseline
Sensory E-Cigarette Expectancies Scale (SEES)
Timeline Followback (TLFB)
modified Cigarette Dependence Scale

Trial Safety

Safety Progress

1 of 3

Trial Design

8 Treatment Groups

High concentration free-base nicotine (5%), Tobacco flavor
1 of 8
High concentration nicotine salt (5%), Tobacco flavor
1 of 8
Low concentration free-base nicotine (1%), Tobacco flavor
1 of 8
Low concentration nicotine salt (1%), Tobacco flavor
1 of 8
High concentration free-base nicotine (5%), Menthol flavor
1 of 8
Low concentration free-base nicotine (1%), Menthol flavor
1 of 8
High concentration nicotine salt (5%), Menthol flavor
1 of 8
Low concentration nicotine salt (1%), Menthol flavor
1 of 8
Experimental Treatment

75 Total Participants · 8 Treatment Groups

Primary Treatment: ECIG lab session 2 · No Placebo Group · N/A

High concentration free-base nicotine (5%), Tobacco flavor
Other
Experimental Group · 1 Intervention: ECIG lab session 1 · Intervention Types: Other
High concentration nicotine salt (5%), Tobacco flavor
Other
Experimental Group · 1 Intervention: ECIG lab session 2 · Intervention Types: Other
Low concentration free-base nicotine (1%), Tobacco flavor
Other
Experimental Group · 1 Intervention: ECIG lab session 5 · Intervention Types: Other
Low concentration nicotine salt (1%), Tobacco flavor
Other
Experimental Group · 1 Intervention: ECIG lab session 6 · Intervention Types: Other
High concentration free-base nicotine (5%), Menthol flavor
Other
Experimental Group · 1 Intervention: ECIG lab session 3 · Intervention Types: Other
Low concentration free-base nicotine (1%), Menthol flavor
Other
Experimental Group · 1 Intervention: ECIG lab session 7 · Intervention Types: Other
High concentration nicotine salt (5%), Menthol flavor
Other
Experimental Group · 1 Intervention: ECIG lab session 4 · Intervention Types: Other
Low concentration nicotine salt (1%), Menthol flavor
Other
Experimental Group · 1 Intervention: ECIG lab session 8 · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0, 5, 10, 35 min.
Closest Location: Ohio State University Comprehensive Cancer Center · Columbus, OH
Photo of Columbus 1Photo of Columbus 2Photo of Columbus 3
2011First Recorded Clinical Trial
1 TrialsResearching E Cigarette Use
203 CompletedClinical Trials

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
281 Previous Clinical Trials
285,743 Total Patients Enrolled
Theodore L Wagener, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
402 Total Patients Enrolled
Marielle Brinkman, BSPrincipal InvestigatorOhio State University

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
You are currently using an e-cigarette, but not nicotine-containing tobacco products.
You are willing to abstain from tobacco and nicotine for at least 12 hours prior to lab sessions.
You are willing to complete five, six hour lab visits.
You must be able to read and speak English.

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.