Respiratory Effects of E-Cigarettes in Obese Youth (RESEC)

RESEC: Respiratory Effects of E-Cigarettes in Obese Youth

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

Study Overview

• Status: Recruiting
• Conditions: E-Cig Use
• Intervention / Treatment: Other: ECIG own; Other: ECIG Vuse

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dharini M Bhammar, PhD; Phone Number: 6143669467; Email: dharini.bhammar@osumc.edu
• Study Contact Backup: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Dharini M Bhammar, PhD; Phone Number: 614-366-9467; Email: dharini.bhammar@osumc.edu
      • Contact: Lisa Brenner; Phone Number: 6142937843; Email: Lisa.Brenner@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaping; All participants will undergo two vaping sessions: one using their own device and one using the study device	Other: ECIG own; Participants will vape using their own ecig device; Other: ECIG Vuse; Participants will vape a VUSE e-cigarette (GOLD 5%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puff count	E-cig puff topography data collection for abuse liability	35 minutes
Average Puff duration	E-cig puff topography data collection for abuse liability	35 minutes
Average Puff volume	E-cig puff topography data collection for abuse liability	35 minutes
Forced expiratory volume in 1 second	Spirometry will be completed before and after a 35 min vaping session	Change from 0 to 35 minutes
Functional residual capacity	Plethymosgraphy will be completed before and after a 35 min vaping session	Change from 0 to 35 minutes
Diffusion capacity	DLCO will be completed before and after a 35 min vaping session	Change from 0 to 35 minutes
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tiffany-Drobes Questionnaire of Smoking Urges	Assess E-cig craving/suppression of craving	Change from 0 to 35 minutes
Respiratory health questionnaire	Assess respiratory symptoms	Change from 0 to 35 minutes
Exhaled carbon monoxide	Assess carbon monoxide in exhaled air	Change from 0 to 35 minutes

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Dharini M Bhammar, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: OSU-22219; NCI-2023-04458 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No