The Acute Cardiovascular Effects of Nicotine in E-cigaret... | NCT03010995

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

NCT03010995

Sponsor

University of Louisville

Status

Withdrawn

Last Update Posted

Jul 26, 2018Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Cigarette Smoking Toxicity
Nicotine
Acute Cardiovascular Disease

Interventions

Prazosin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study discontinued due to lack of study funding.

Expanded Access Info

Start Date

Mar 13, 2018Actual

Primary Completion Date

Jul 24, 2018Actual

Completion Date

Jul 24, 2018Actual

First Submitted Date

Dec 9, 2016

First Submission Date that Met QC Criteria

Jan 3, 2017

First Posted Date

Jan 5, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2018

Last Update Posted Date

Jul 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
18 mg nicotine	Active Comparator	E-cigarette with 18 mg nicotine	Drug: Prazosin
9 mg nicotine	Active Comparator	E-cigarette with 9 mg nicotine	Drug: Prazosin
0 mg nicotine	Placebo Comparator	E-cigarette with 0 mg nicotine	Drug: Prazosin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prazosin	Drug	Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes	0 mg nicotine 18 mg nicotine 9 mg nicotine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant will be currently healthy individuals, between 18 and 40 years of age.
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
Participants willing to abstain from vaping, smoking and tobacco for 12 hours prior to study.
Do not meet any of the Exclusion criteria.

Exclusion Criteria:

Unwilling or unable to provide informed consent.
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.
Body weight less than 100 pounds or BMI >40.
Participants that are taking the following medications: estrogen, testosterone, anti TNF agents, cyclophosphamide, ketoconazole, methoxsalen, pilocarpine, Isoniazid, rifampicin certain biologics, or Procrit
Participants that are currently using nicotine patches, nicotine gum or any form of nicotine-containing cessation device
Pregnant or lactating women.
Prisoners and other vulnerable populations.
Anyone that PI thinks is unsafe to participate in the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Louisville		Louisville	Kentucky	40202	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012907	Smoking
D001519	Behavior

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds