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| Name | Class |
|---|---|
| Davita Clinical Research | INDUSTRY |
| RAI Services Company | INDUSTRY |
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A single-center, randomized, controlled, switching, open-label, parallel cohort study. Smoking subjects will be confined to a clinic for 9 days. During their stay, baseline assessments during ad libitum smoking will occur for the first 3 days. Following baseline, subjects will be switched to either an Electronic Cigarette or Nicotine Gum, and post-product switch assessments will occur for 6 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Brand (UB) Cigarettes | Active Comparator | Usual Brand Cigarette |
|
| Electronic Cigarette #1 | Experimental | VUSEĀ® (original flavor, 29 mg nicotine) |
|
| Electronic Cigarette #2 | Experimental | VUSEĀ® (menthol flavor, 26 mg nicotine) |
|
| Leading U.S. Nicotine Gum | Experimental | 4 mg nicotine polacrilex gum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Brand Cigarette | Other | Combustible cigarette brand style smoked most frequently by subject |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in carboxyhemoglobin (COHb), after 5 days of randomized IP use compared to UB smoking | 6 days |
| Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence | Determine area under the plasma nicotine concentration versus time curve (AUC) | -5, -0.5, 3, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes |
| Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence | Determine maximum plasma nicotine concentration (Cmax), baseline adjusted | -5, -0.5, 3, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes |
| Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence | Determine maximum plasma nicotine concentration (Tmax) | -5, -0.5, 3, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes |
| Subjective effects scores for Urge to Smoke (UTS) | Determine trends in Urge to Smoke | Three times during baseline UB cigarette smoking and 3 times per day for 5 days after switch to randomized IP use |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum |
| Measure | Description | Time Frame |
|---|---|---|
| Daily product use amounts | Daily during baseline UB cigarette smoking and each day for 5 days after switch to randomized IP use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Alcorn, Jr., PharmD | Davita Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
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| Electronic Cigarette #1 | Other | Electronic cigarette |
|
|
| Electronic Cigarette #2 | Other | Electronic cigarette |
|
|
| Leading U.S. Nicotine Gum | Other | 4 mg nicotine polacrilex gum |
|
Determine trends in plasma nicotine and cotinine during randomized IP use compared to UB smoking |
| 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary total nicotine equivalents (Nicotine + 10 metabolites), after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary nitrosamines and metabolites, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 3-aminobiphenyl, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 4-aminobiphenyl, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 1-aminonaphthalene, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 2-aminonaphthalene, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary o-toluidine, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary S-phenyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 1-hydroxypyrene, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 3-hydroxy-benzo[a]pyrene, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 1-hydroxynapthalene, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 2-hydroxynaphthalene, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 2-hydroxyfluorene, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary N-acetyl-S-(3-amino-3-oxypropyl) cysteine, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary N-acetyl-S-(3-amino-2-hydroxy-3-oxopropyl) cysteine, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 3-hydroxypropyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 3-hydroxy-1-methylpropyl-mercapturic acid, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary monohydroxybutyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 2-cyanoethyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary 2-hydroxyethyl mercapturic acid, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary thiocyanate, after 5 days of randomized IP use compared to UB smoking | 6 days |
| Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum | Determine percent change in urinary mutagenicity, after 5 days of randomized IP use compared to UB smoking | 6 days |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D008610 | Menthol |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |
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