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| Name | Class |
|---|---|
| Tobacco Related Disease Research Program | OTHER |
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Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization.
Non-user or chronic electronic cigarette (EC) users will use an EC or control on three occasions:1) EC with nicotine, 2) EC without nicotine, 3) empty EC (control).
Chronic tobacco cigarette (TC) smokers will use a TC or control on three occasions: 1) TC with nicotine (subject's own brand), 2) research TC with very low nicotine, 3) straw (control). The electrocardiogram will be recorded before and after acute exposures and analyzed for parameters representative of ventricular repolarization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-user | Experimental | Non- users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control) |
|
| Chronic EC user | Experimental | Chronic EC users will use, in a randomized, crossover fashion with a 4 week washout, an 1) EC with nicotine, 2) EC without nicotine, and 3) an empty EC (control) |
|
| Chronic TC smoker | Experimental | Chronic TC smokers will use, in a randomized, crossover fashion with a 4 week washout, a 1) TC with nicotine (own brand), 2) research TC with very low level nicotine, and 3) a straw (control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EC with nicotine | Other | Use an EC with nicotine for up to 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tpe | interval indicative of ventricular repolarization measured on ECG | Change in Tpe 5 minutes before and 5 minutes after cigarette use |
| Tpe/QT | ratio of intervals indicative of ventricular repolarization measured on ECG | Change in Tpe/QT 5 minutes before and 5 minutes after cigarette use |
| Tpe/QTc | ratio of intervals indicative of ventricular repolarization measured on ECG | Change in Tpe/QTc 5 minutes before and 5 minutes after cigarette use |
| Measure | Description | Time Frame |
|---|---|---|
| QT | interval indicative of ventricular repolarization measured on ECG | Change in QT 5 minutes before and 5 minutes after cigarette use |
| QTc | interval indicative of ventricular repolarization measured on ECG |
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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 |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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Crossover with 4 week washout
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Single (outcomes assessor) code
| EC without nicotine | Other | Use an EC without nicotine for up to 30 minutes |
|
| control | Other | sham control |
|
| TC with nicotine (own brand) | Other | smoke a TC |
|
| research TC with very low level nicotine | Other | smoke a research TC with very low level nicotine |
|
| Change in QTc 5 minutes before and 5 minutes after cigarette use |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012907 | Smoking |
| D001519 | Behavior |
| D006573 |
| Heterocyclic Compounds, 1-Ring |