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Respiratory Effects of E-Cigarettes in Obese Youth

Not Applicable
Active, not recruiting
Conditions
E-Cig Use
Interventions
Other: ECIG own
Other: ECIG Vuse
Registration Number
NCT05869318
Lead Sponsor
Ohio State University Comprehensive Cancer Center
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
56
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
VapingECIG ownAll participants will undergo two vaping sessions: one using their own device and one using the study device
VapingECIG VuseAll participants will undergo two vaping sessions: one using their own device and one using the study device
Primary Outcome Measures
NameTimeMethod
Diffusion capacityChange from 0 to 35 minutes

DLCO will be completed before and after a 35 min vaping session

Forced expiratory volume in 1 secondChange from 0 to 35 minutes

Spirometry will be completed before and after a 35 min vaping session

Average Puff duration35 minutes

E-cig puff topography data collection for abuse liability

Functional residual capacityChange from 0 to 35 minutes

Plethymosgraphy will be completed before and after a 35 min vaping session

Airway resistanceChange from 0 to 35 minutes

Plethymosgraphy to measure airway resistance (Raw) will be completed before and after a 35 min vaping session

Puff count35 minutes

E-cig puff topography data collection for abuse liability

Average Puff volume35 minutes

E-cig puff topography data collection for abuse liability

Secondary Outcome Measures
NameTimeMethod
Tiffany-Drobes Questionnaire of Smoking UrgesChange from 0 to 35 minutes

Assess E-cig craving/suppression of craving

Respiratory health questionnaireChange from 0 to 35 minutes

Assess respiratory symptoms

Exhaled carbon monoxideChange from 0 to 35 minutes

Assess carbon monoxide in exhaled air

Trial Locations

Locations (1)

The Ohio State University

🇺🇸

Columbus, Ohio, United States

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