Vascular Effects of a Single Bout of Electronic Cigarette Use

NCT03209661 | Completed Phase 1 FDA Drug

• 1 other identifier: 2016-04-0115
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Investigating the acute effects of a single use E-Cigarette upon vascular health.

Conditions

Arterial Stiffness

Keywords

vascular function

Outcome Measures

Primary Outcomes (1)

• Changes in arterial stiffness and endothelial function with e-cigarette use.

  Arterial stiffness and endothelial function are two of the subclinical markers of vascular dysfunction

  Immediately Post, 1 hour, and 2 hour.

Study Arms (3)

E-Cigarette 5.4% NBV

ACTIVE COMPARATOR

Subjects will be asked to inhale an E-Cigarette with 5.4% NBV for 6 min.

Drug: E-cigarette

E-Cigarette 0% NBV

PLACEBO COMPARATOR

Subjects will be asked to inhale an E-Cigarette with 0% NBV for 6 min.

Drug: Nicotine 0%

Menthol Inhaler

PLACEBO COMPARATOR

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

Interventions

E-cigarette DRUG

E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function.

Also known as: Nicotine 5.4%

E-Cigarette 5.4% NBV

Nicotine 0% DRUG

E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function.

Also known as: Placebo

E-Cigarette 0% NBV

Menthol Inhalant Product DRUG

Menthol inhaler will be administered to determine the effects on vascular function.

Also known as: Placebo

Menthol Inhaler

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apparently healthy, with no cardiovascular or metabolic diseases. Additionally, is not a frequent smoker of any kind.

You may not qualify if:

• Cardiovascular or Metabolic Diseases and/or regular smoker.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Cardiovascular Aging Research Lab at UT Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Cossio R, Cerra ZA, Tanaka H. Vascular effects of a single bout of electronic cigarette use. Clin Exp Pharmacol Physiol. 2020 Jan;47(1):3-6. doi: 10.1111/1440-1681.13180. Epub 2019 Oct 7.

  PMID: 31531991 DERIVED

MeSH Terms

Interventions

Electronic Nicotine Delivery Systems

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Hirofumi Tanaka, Phd

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 6, 2017
• Study Start: April 28, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 31, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)