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| Name | Class |
|---|---|
| Vince & Associates Clinical Research, Inc. | OTHER |
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The purpose of this clinical study is to evaluate changes in biomarkers of exposure (BOE) to tobacco smoke constituents after smokers switch from combustible cigarettes to use of one of the three electronic cigarettes or abstinence.
This will be a two-center, randomized, controlled, switching, open-label, parallel cohort study. The study will compare biomarkers of tobacco exposure from subjects at baseline levels of biomarkers of tobacco exposure after they have switched to one of three electronic cigarettes or abstinence for 5 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FT21039 Product Use Group | Experimental | Subjects will use the electronic cigarette product (FT21039). |
|
| FT21092 Product Use Group | Experimental | Subjects will use the electronic cigarette product (FT21092). |
|
| FT21018 Product Use Group | Experimental | Subjects will use the electronic cigarette product (FT21018). |
|
| Abstinence Group | No Intervention | Subjects in the Abstinence Group will not be assigned any products. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT21039 | Other | an electronic cigarette product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5 | A comparison of biomarkers of tobacco exposure in urine from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in urine include:
| 5 days |
| Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5 | A comparison of biomarkers of tobacco exposure in blood from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in blood include: 1. Carboxyhemoglobin | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5 | A comparison of biomarkers of tobacco exposure in urine from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in urine include:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra Kelsh, MD | Vince & Associates Clinical Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince & Associates Clinical Research, Inc. | Overland Park | Kansas | 66212 | United States | ||
| DaVita Clinical Research |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| FT21092 |
| Other |
an electronic cigarette product |
|
| FT21018 | Other | an electronic cigarette product |
|
| 5 days |
| Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5 | A comparison of biomarkers of tobacco exposure in blood from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence. Biomarkers of tobacco exposure in blood include:
| 5 days |
| Minneapolis |
| Minnesota |
| 55404 |
| United States |