NCT03916341

Brief Summary

Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

3.5 years

First QC Date

April 10, 2019

Last Update Submit

October 2, 2023

Conditions

Sudden Cardiac DeathProlonged QTc Interval

Keywords

e-cigarettestobacco cigarettesnicotineventricular repolarization

Outcome Measures

Primary Outcomes (3)

  • Tpe

    interval indicative of ventricular repolarization measured on ECG

    Change in Tpe 5 minutes before and 5 minutes after cigarette use

  • Tpe/QT

    ratio of intervals indicative of ventricular repolarization measured on ECG

    Change in Tpe/QT 5 minutes before and 5 minutes after cigarette use

  • Tpe/QTc

    ratio of intervals indicative of ventricular repolarization measured on ECG

    Change in Tpe/QTc 5 minutes before and 5 minutes after cigarette use

Secondary Outcomes (2)

  • QT

    Change in QT 5 minutes before and 5 minutes after cigarette use

  • QTc

    Change in QTc 5 minutes before and 5 minutes after cigarette use

Study Arms (3)

Non-user

EXPERIMENTAL

Non- users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control)

Other: EC with nicotineOther: EC without nicotineOther: control

Chronic EC user

EXPERIMENTAL

Chronic EC users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control)

Other: EC with nicotineOther: EC without nicotineOther: control

Chronic TC smoker

EXPERIMENTAL

Chronic TC smokers will use, in a randomized, crossover fashion with a 4 week washout, a 1) TC with nicotine (own brand), 2) research TC with very low level nicotine, and 3) a straw (control)

Other: controlOther: TC with nicotine (own brand)Other: research TC with very low level nicotine

Interventions

EC with nicotineOTHER

Use an EC with nicotine for up to 30 minutes

Chronic EC userNon-user
EC without nicotineOTHER

Use an EC without nicotine for up to 30 minutes

Chronic EC userNon-user
controlOTHER

sham control

Chronic EC userChronic TC smokerNon-user
TC with nicotine (own brand)OTHER

smoke a TC

Chronic TC smoker
research TC with very low level nicotineOTHER

smoke a research TC with very low level nicotine

Chronic TC smoker

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy non-smokers chronic TC smokers (non-e-cig users) Chronic EC smokers (Non-TC smokers)

You may not qualify if:

  • Cardiac disease, respiratory disease, diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCaliforniaLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Death, Sudden, CardiacVaping

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsSmokingBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (outcomes assessor) code
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Crossover with 4 week washout
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 16, 2019

Study Start

October 1, 2019

Primary Completion

April 10, 2023

Study Completion

April 10, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)