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

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.

Study Overview

• Status: Withdrawn
• Conditions: Nicotine; Cigarette Smoking Toxicity; Acute Cardiovascular Disease
• Intervention / Treatment: Drug: Prazosin

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 Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial function	Flow mediated dilatation	Change between baseline and post exposure 20-30 mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate monitor	Change between baseline and post exposure 5,10, 30, 60, 120 mins
Blood pressure	Blood pressure monitor	Change between baseline and post exposure 5,10, 30, 60, 120 mins
Heart Rate Variability	SphygmoCor HRV system SCOR-Hx	Change between baseline and post exposure 20 mins
Nicotine levels in plasma	Detect plasma nicotine levels	Change between Baseline and over 2 hours

Collaborators and Investigators

• Sponsor: University of Louisville

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 13, 2018
• Primary Completion (ACTUAL): July 24, 2018
• Study Completion (ACTUAL): July 24, 2018

Study Registration Dates

• First Submitted: December 9, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (ESTIMATE): January 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: electronic cigarette; endothelial function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Prazosin
• Other Study ID Numbers: 16.1079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No