Respiratory Effects of E-Cigarettes in Obese Youth

E-Cig Use Clinical Trial

— RESEC  

Official title:

RESEC: Respiratory Effects of E-Cigarettes in Obese Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869318
• Other study ID #: OSU-22219
• Secondary ID: NCI-2023-04458
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: Dharini M Bhammar, PhD
• Phone: 6143669467
• Email: dharini.bhammar[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine vaping behaviors and respiratory function in obese and nonobese youth e-cigarette users.

Description:

The investigators hypothesize that obese youth e-cigarette users will have increased e-cigarette use that will worsen respiratory function. The approach will involve a clinical trial where vaping behaviors (using puff topography) and respiratory function (spirometry, plethysmography, and diffusion capacity) will be assessed while participants vape with their own e-cigarette and, on a separate visit, with the VUSE e-cigarette.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 25 Years

Eligibility

Inclusion Criteria:

• a current e-cigarette user (=1 vaping bout daily) for at least the past 3 months,
• 21-25 years old,
• willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions,
• willing to complete five lab visits lasting up to 4 hours each,
• able to read and speak English,
• willing to provide informed consent.

Exclusion Criteria:

• self-reported diagnosis of lung disease including asthma or cystic fibrosis
• history of cardiac event or distress within the past 3 months
• history of metabolic disease including thyroid disease or diabetes
• history of orthopedic or neuromuscular problems that preclude exercise
• currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding
• use of other tobacco products >10 days in the past month
• current marijuana use >10 times per month
• currently engaging in a vaping cessation attempt
• ) competitive athlete or individual currently engaged in an exercise training program involving 420min or more (moderate intensity aerobic activity) or 210 min or more (vigorous intensity aerobic activity) per week with the goal of participating in a competitive event or marathon, triathlon, etc. Participants who are engaged in usual physical activity (e.g., walking dog, biking to work, etc.) but not engaged in a "structured exercise training program" will not be excluded.
• plans to leave the Columbus or central Ohio region within the next year.

Related Conditions & MeSH terms

• E-Cig Use

Intervention

Other:
• ECIG own
Participants will vape using their own ecig device
• ECIG Vuse
Participants will vape a VUSE e-cigarette (GOLD 5%)

Locations

Country	Name	City	State
United States	The Ohio State University	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	Forced expiratory volume in 1 second	Spirometry will be completed before and after a 35 min vaping session	Change from 0 to 35 minutes
Primary	Functional residual capacity	Plethymosgraphy will be completed before and after a 35 min vaping session	Change from 0 to 35 minutes
Primary	Diffusion capacity	DLCO will be completed before and after a 35 min vaping session	Change from 0 to 35 minutes
Primary	Airway resistance	Plethymosgraphy to measure airway resistance (Raw) will be completed before and after a 35 min vaping session	Change from 0 to 35 minutes
Primary	Puff count	E-cig puff topography data collection for abuse liability	35 minutes
Primary	Average Puff duration	E-cig puff topography data collection for abuse liability	35 minutes
Primary	Average Puff volume	E-cig puff topography data collection for abuse liability	35 minutes
Secondary	Tiffany-Drobes Questionnaire of Smoking Urges	Assess E-cig craving/suppression of craving	Change from 0 to 35 minutes
Secondary	Respiratory health questionnaire	Assess respiratory symptoms	Change from 0 to 35 minutes
Secondary	Exhaled carbon monoxide	Assess carbon monoxide in exhaled air	Change from 0 to 35 minutes