Vascular Effects of a Single Bout of Electronic Cigarette Use
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|ClinicalTrials.gov Identifier: NCT03209661|
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Arterial Stiffness||Drug: E-cigarette Drug: Nicotine 0% Drug: Menthol Inhalant Product||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Subjects will be asked to inhale one of three mediums; 5.4% NBV e-ciggarette, 0% NBV cigarette, and sham menthol inhaler (no vapor). Baseline measurements will be conducted upon arrival and followed immediately post inhalation, 1-hour post, and finally 2-hours post. All trials will require a minimum of 48 hours washout.|
|Masking Description:||E-cigarettes being utilized are of the same brand and design. Additionally, the device will be covered by a sheath to ensure labeling is not visible to the subject.|
|Official Title:||Vascular Effects of a Single Bout of Electronic Cigarette Use|
|Actual Study Start Date :||April 28, 2017|
|Actual Primary Completion Date :||August 1, 2018|
|Actual Study Completion Date :||August 31, 2018|
Active Comparator: E-Cigarette 5.4% NBV
Subjects will be asked to inhale an E-Cigarette with 5.4% NBV for 6 min.
E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function.
Other Name: Nicotine 5.4%
Placebo Comparator: E-Cigarette 0% NBV
Subjects will be asked to inhale an E-Cigarette with 0% NBV for 6 min.
Drug: Nicotine 0%
E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function.
Other Name: Placebo
Placebo Comparator: Menthol Inhaler
Subjects will be asked to inhale a sham methole inhaler (that looks identical in looks to E-cigarette) for 6 minutes. This arm is to control for a potential effect of menthole.
Drug: Menthol Inhalant Product
Menthol inhaler will be administered to determine the effects on vascular function.
Other Name: Placebo
- Changes in arterial stiffness and endothelial function with e-cigarette use. [ Time Frame: Immediately Post, 1 hour, and 2 hour. ]Arterial stiffness and endothelial function are two of the subclinical markers of vascular dysfunction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209661
|United States, Texas|
|Cardiovascular Aging Research Lab at UT Austin|
|Austin, Texas, United States, 78712|
|Principal Investigator:||Hirofumi Tanaka, Phd||University of Texas|