Overview

The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study

Status:
Withdrawn

Trial end date:
2018-07-24

Target enrollment:
0

Participant gender:
All

Summary

The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in E-Cigarette users and also study the mechanism involved particularly with vascular impairment.

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

University of Louisville

Treatments:

Nicotine
Prazosin

Criteria

Inclusion Criteria:

1. Participant will be currently healthy individuals, between 18 and 40 years of age.

2. E-Cigarette users using E-Cigarette for at least 1 month and smoke ≤ 1 tobacco
cigarette / day; non-smokers who used less than 100 tobacco cigarettes in their
lifetime and are not active nicotine/tobacco or related product users

3. Participants willing to abstain from vaping, smoking and tobacco for 12 hours prior to
study.

4. Do not meet any of the Exclusion criteria.

Exclusion Criteria:

1. Unwilling or unable to provide informed consent.

2. Participant that have: Diabetes, Hypertension HIV, hepatitis, liver disease (including
fatty liver), anemia, unhealed wounds, active infection, febrile, anemia, organ
transplant, renal replacement therapy, kidney disease or insufficiency, dialysis,
active cancer of any type, and untreated thyroid disease, major injury or trauma.

3. Body weight less than 100 pounds or BMI >40.

4. Participants that are taking the following medications: estrogen, testosterone, anti
TNF agents, cyclophosphamide, ketoconazole, methoxsalen, pilocarpine, Isoniazid,
rifampicin certain biologics, or Procrit

5. Participants that are currently using nicotine patches, nicotine gum or any form of
nicotine-containing cessation device

6. Pregnant or lactating women.

7. Prisoners and other vulnerable populations.

8. Anyone that PI thinks is unsafe to participate in the study.