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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA058271-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 3 exposure groups. These include a high oxidant little cigar exposure condition, a low oxidant little cigar exposure condition, and their usual cigarette. Biological samples will be collected before and after product usage.
Exhaled breath condensate samples will be collected at pre-product usage, post-product usage, 30, and 60 minutes. Samples will be analyzed for levels of oxidant markers including 8-isoprostanes, 8-OHdG acrolein adducts and C-reactive protein.
Exhaled breath samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for levels of oxidant markers in Volitive Organic Compound (VOC) profiles.
Blood samples will be collected at pre-product usage and post-product usage. Samples will be analyzed nicotine, 8-isoprostane and other oxidative makers of stress.
Buccal cell samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts.
Salvia samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts and metabolomic profiles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects will be given the high oxidant little cigar for their first laboratory visit. They will then be given the low oxidant little cigar for the second visit followed by using their own cigarette at the final laboratory visit. |
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| Group B | Experimental | Subjects will be given the low oxidant little cigar for their first laboratory visit. They will then use their own cigarette for the second visit followed by being given the high oxidant little cigar at the final laboratory visit. |
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| Group C | Experimental | Subjects will use their own cigarette for their first laboratory visit. They will then be given the high oxidant little cigar for the second visit followed by being given the low oxidant little cigar at the final laboratory visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Oxidant Little Cigar | Other | Subjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage. |
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| Measure | Description | Time Frame |
|---|---|---|
| 8-isoprostanes Concentration in Exhaled Breath Condensate | -5 minutes | |
| 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate | -5 minutes | |
| C-reactive Protein Concentration in Exhaled Breath Condensate | -5 minutes | |
| 8-isoprostanes Concentration in Exhaled Breath Condensate | 0 minutes | |
| 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate | 0 minutes | |
| C-reactive Protein Concentration in Exhaled Breath Condensate | 0 minutes | |
| 8-isoprostanes Concentration in Exhaled Breath Condensate | 30 minutes | |
| 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate | 30 minutes | |
| C-reactive Protein Concentration in Exhaled Breath Condensate | 30 minutes | |
| 8-isoprostanes Concentration in Exhaled Breath Condensate | 60 minutes | |
| 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joshua Muscat, Ph.D. | Contact | 7175318521 | jmuscat@pennstatehealth.psu.edu | |
| Kenneth Houser, MS | Contact | 7175315473 | khouser@pennstatehealth.psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Muscat, Ph.D. | Penn State Hershey College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Williams Design for Cross over-trials with a 3-period 3-treatment cross-over design in 36 healthy daily cigarette smokers.
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| Low Oxidant Little Cigar | Other | Subjects will be given a low oxidant little cigar to use for outcome measure data collection in the lab before and after product usage. |
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| Usual Cigarette | Other | Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage. |
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| 60 minutes |
| C-reactive Protein Concentration in Exhaled Breath Condensate | 60 minutes |
| Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples | -5 minutes |
| Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples | 0 minutes |
| Nicotine concentration in Blood Samples | -5 minutes |
| Nicotine concentration in Blood Samples | 0 minutes |
| 8-isoprostanes Concentration in Blood Samples | -5 minutes |
| 8-isoprostanes Concentration in Blood Samples | 0 minutes |
| 8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples | -5 minutes |
| 8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples | 0 minutes |
| 8-OHdg Acrolein Adduct Concentration in Saliva Samples | -5 minutes |
| 8-OHdg Acrolein Adduct Concentration in Saliva Samples | 0 minutes |
| Metabolomic Profiles in Saliva Samples | -5 minutes |
| Metabolomic Profiles in Saliva Samples | 0 minutes |