Impact of E-cigarette Use on the Body

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

The Emerging Adulthood Health Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04972513
• Other study ID #: OSU-20320
• Secondary ID: NCI-2021-06438
• Status: Active, not recruiting
• Start date: July 22, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study examines how electronic (e)-cigarette use impacts the body, by studying both users and non-users of e-cigarettes. Early evidence indicates that e-cig users experience adverse health effects. Results of this study may help policy-makers develop standards for different types of tobacco.

Description:

PRIMARY OBJECTIVE:

Examine the short-term impacts of vaping on pulmonary and respiratory outcomes.

OUTLINE:

Current e-cigarette users will vape their own e-cigarette device ad libitum for 30 minutes; non-users will watch a neutral video for 30 minutes. Before and after the 30 minute vaping [video] session, participants will undergo the following assessments: computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function. Participants will also undergo collection of blood.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: December 31, 2024
• Est. primary completion date: June 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

Inclusion Criteria:

• 75 e-cig users and 75 never-users

• No self-reported diagnosis of lung disease (e.g., coronavirus disease-2019 [COVID-19], pneumonia, cystic fibrosis)

• No history of cardiac event or distress

• Not currently breastfeeding, pregnant, or planning to become pregnant (e-cig users only; will be confirmed via pregnancy test)

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood
• Nitric Oxide Breath Test
Undergo nitric oxide breath testing
• Oscillometry
Undergo airwave oscillometry
• Spirometry
Undergo spirometry

Other:
• Survey Administration
Complete survey

Procedure:
• Endothelial function
Endothelial function will be assessed with the EndoPAT device, which measures changes in pressure from sensors placed on the fingertip

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway inflammation as assessed by exhaled nitric oxide	Exhaled nitric oxide will be measured in parts per billion (ppb)	Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Primary	Airway reactivity as assessed by airwave oscillometry	Airway reactivity will be measured via Tremoflo, which is a well validated measurement of airway reactivity and provides curves of Resistance (R) and Reactance (X)	Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Primary	Respiratory functioning as assessed by a mobile Spirometry device	Spirometry will collect daily data from participants on the relationship between their forced expiratory volume and forced vital capacity (measured as FEV1/FVC).	Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Primary	Endothelial function	Endothelial function will be assessed with the EndoPAT device (unit of measurement = LnRHI).	Procedure will last approximately 20 minutes; the procedure will occur twice during the laboratory session (separated by approximately 90 minutes)

External Links

•   The Jamesline