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Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity
Participants will have an acute exposure on 4 occasions1) e-cigarette with nicotine, 2) e-cigarette without nicotine, 3) nicotine inhaler, 4) sham control and undergo ECG recording for heart rate variability, endothelial function measurement using ultrasound ("FMD") and blood tests for oxidative stress markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine: use e-cig with nicotine | Experimental | One time exposure to e-cig with nicotine |
|
| no nicotine: use e-cig without nicotine | Experimental | One time exposure to e-cig without nicotine |
|
| Nicotine inhaler: use a nictoine inhaler | Experimental | One time exposure to nicotine inhaler |
|
| Sham control | Sham Comparator | Use an empty e-cigarette |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-cig with nicotine | Other | use an e-cig with nicotine for 30 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated dilatation (FMD) | FMD is a measure of endothelial function | 10 minutes after exposure |
| Heart rate variability (HRV) | HRV is a measure of cardiac sympathetic tone | 10 minutes after exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Paraoxonase (PON) | PON is a measure of oxidative stress | ~30 minutes after exposure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCaliforniaLA | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D012991 | Solanaceous Alkaloids |
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| e-cig without nicotine |
| Other |
use an e-cig without nicotine for 30 minutes |
|
| nicotine inhaler | Other | use a nicotine inhaler for 30 minutes |
|
| sham control | Other | use an empty e-cigarette for 30 minutes |
|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |