Vascular Effects of a Single Bout of Electronic Cigarette Use

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Arterial Stiffness

Treatments: Drug: E-cigarette; Drug: Menthol Inhalant Product; Drug: Nicotine 0%

Study type: Interventional

Funder types: Other

Identifiers

NCT03209661

2016-04-0115

Details and patient eligibility

About

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

Full description

Subjects will inhale e-cigarettes of 5.4%, 0%, and sham menthol inhaler to determine the effects upon to measures of vascular health. These measures will include Cardio-Ankle Vascular Index and Flow Mediated Dilation.

Enrollment: 16 patients

Sex: All

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Cardiovascular or Metabolic Diseases and/or regular smoker.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 3 patient groups, including a placebo group

E-Cigarette 5.4% NBV

Active Comparator group

Description:

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

Treatment:

Drug: E-cigarette

E-Cigarette 0% NBV

Placebo Comparator group

Description:

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

Treatment:

Drug: Nicotine 0%

Menthol Inhaler

Placebo Comparator group

Description:

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.

Treatment:

Drug: Menthol Inhalant Product