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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-04458 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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To determine vaping behaviors and respiratory function in obese and nonobese youth e-cigarette users.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaping | Experimental | All participants will undergo two vaping sessions: one using their own device and one using the study device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECIG own | Other | Participants will vape using their own ecig device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dharini M Bhammar, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 12, 2024 | Oct 15, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ECIG Vuse |
| Other |
Participants will vape a VUSE e-cigarette (GOLD 5%) |
|
| Change from 0 to 35 minutes |
| Exhaled carbon monoxide | Assess carbon monoxide in exhaled air | Change from 0 to 35 minutes |