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

Nicotine Clinical Trial

— ACE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03010995
• Other study ID #: 16.1079
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 13, 2018
• Est. completion date: July 24, 2018

Study information

• Verified date: July 2018
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

We will recruit 30 experienced E-cigarette users (those using E-Cigarette for at least 1 month and ≤ 1 tobacco cigarette / day), between ages 21-40 years; in 4 day study visit and 10 non-smokers (those who used less than 100 tobacco cigarettes in their lifetime and not active nicotine/tobacco or related product user) for a one study visit.The participants will be asked to abstain from all tobacco/nicotine and related product use for 12 hours before each visit.

Measurements will be taken at each study visit before and after E-cigarette use, each day with different nicotine dose, to look at both the individuals' exposure to nicotine and also the effects on the cardiovascular system. These measurements will include blood and urine samples as well as non-invasive cardiovascular measurements.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 24, 2018
• Est. primary completion date: July 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Cardiovascular Disease
• Cardiovascular Diseases
• Cigarette Smoking Toxicity
• Nicotine

Intervention

Drug:
• Prazosin
Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function	Flow mediated dilatation	Change between baseline and post exposure 20-30 mins
Secondary	Heart rate	Heart rate monitor	Change between baseline and post exposure 5,10, 30, 60, 120 mins
Secondary	Blood pressure	Blood pressure monitor	Change between baseline and post exposure 5,10, 30, 60, 120 mins
Secondary	Heart Rate Variability	SphygmoCor HRV system SCOR-Hx	Change between baseline and post exposure 20 mins
Secondary	Nicotine levels in plasma	Detect plasma nicotine levels	Change between Baseline and over 2 hours