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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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