Clinical trial NCT05869318: Respiratory Effects of E-Cigarettes in Obese Youth
Official title: RESEC: Respiratory Effects of E-Cigarettes in Obese Youth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: E-Cig Use
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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, delivered a child in the past 6 weeks even if not breastfeeding, or currently 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.

Primary outcomes:
measure: Forced expiratory volume in 1 second
timeFrame: Change from 0 to 35 minutes
measure: Functional residual capacity
timeFrame: Change from 0 to 35 minutes
measure: Diffusion capacity
timeFrame: Change from 0 to 35 minutes
measure: Airway resistance
timeFrame: Change from 0 to 35 minutes
measure: Puff count
timeFrame: 35 minutes
measure: Average Puff duration
timeFrame: 35 minutes
measure: Average Puff volume
timeFrame: 35 minutes
Secondary outcomes:
measure: Tiffany-Drobes Questionnaire of Smoking Urges
timeFrame: Change from 0 to 35 minutes
measure: Respiratory health questionnaire
timeFrame: Change from 0 to 35 minutes
measure: Exhaled carbon monoxide
timeFrame: Change from 0 to 35 minutes
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Dharini M Bhammar, PhD
role: PRINCIPAL_INVESTIGATOR
References: