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

• Sponsor: University of Louisville (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03010995
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 3
• Actual Duration (Months): 4.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cigarette Smoking Toxicity; Nicotine; Acute Cardiovascular Disease	Drug: Prazosin	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: All the outcome measurements will be performed by staff that will be blinded to the participant and their exposure.
• Primary Purpose: Other
• Official Title: The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study
• Actual Study Start Date: Mar 13, 2018
• Actual Primary Completion Date: Jul 24, 2018
• Actual Study Completion Date: Jul 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 18 mg nicotine E-cigarette with 18 mg nicotine	Drug: Prazosin; Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes
Active Comparator: 9 mg nicotine E-cigarette with 9 mg nicotine	Drug: Prazosin; Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes
Placebo Comparator: 0 mg nicotine E-cigarette with 0 mg nicotine	Drug: Prazosin; Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes

Outcome Measures

Primary Outcome Measures

1. Endothelial function [Change between baseline and post exposure 20-30 mins]

   Flow mediated dilatation

Secondary Outcome Measures

1. Heart rate [Change between baseline and post exposure 5,10, 30, 60, 120 mins]

   Heart rate monitor

2. Blood pressure [Change between baseline and post exposure 5,10, 30, 60, 120 mins]

   Blood pressure monitor

3. Heart Rate Variability [Change between baseline and post exposure 20 mins]

   SphygmoCor HRV system SCOR-Hx

4. Nicotine levels in plasma [Change between Baseline and over 2 hours]

   Detect plasma nicotine levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Affan B. Irfan, Principal investigator, University of Louisville
• ClinicalTrials.gov Identifier: NCT03010995
• Other Study ID Numbers: 16.1079
• First Posted: Jan 5, 2017
• Last Update Posted: Jul 26, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Affan B. Irfan, Principal investigator, University of Louisville: electronic cigarette; endothelial function
• Additional relevant MeSH terms: Cardiovascular Diseases; Prazosin

Study Results

No Results Posted as of Jul 26, 2018