RESEC: Respiratory Effects of E-Cigarettes in Obese Youth

• Sponsor: Ohio State University Comprehensive Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05869318
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 56.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
E-Cig Use	Other: ECIG own; Other: ECIG Vuse	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: RESEC: Respiratory Effects of E-Cigarettes in Obese Youth
• Actual Study Start Date: Apr 4, 2023
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

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%)

Outcome Measures

Primary Outcome Measures

1. Forced expiratory volume in 1 second [Change from 0 to 35 minutes]

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

2. Functional residual capacity [Change from 0 to 35 minutes]

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

3. Diffusion capacity [Change from 0 to 35 minutes]

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

4. Airway resistance [Change from 0 to 35 minutes]

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

5. Puff count [35 minutes]

   E-cig puff topography data collection for abuse liability

6. Average Puff duration [35 minutes]

   E-cig puff topography data collection for abuse liability

7. Average Puff volume [35 minutes]

   E-cig puff topography data collection for abuse liability

Secondary Outcome Measures

1. Tiffany-Drobes Questionnaire of Smoking Urges [Change from 0 to 35 minutes]

   Assess E-cig craving/suppression of craving

2. Respiratory health questionnaire [Change from 0 to 35 minutes]

   Assess respiratory symptoms

3. Exhaled carbon monoxide [Change from 0 to 35 minutes]

   Assess carbon monoxide in exhaled air

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University Comprehensive Cancer Center

Investigators

• Principal Investigator: Dharini M Bhammar, PhD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dharini Bhammar, Assistant Professor, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT05869318
• Other Study ID Numbers: 2022C0202
• First Posted: May 22, 2023
• Last Update Posted: May 22, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 22, 2023