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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA042532 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to evaluate reactions to, and choices to self-administer, cigarette smoke with varying nicotine content among low-frequency, non-dependent adolescent/young adult smokers between the ages of 15-25 years.
Participants will undergo three sessions in which their reactions to fixed doses of smoke from investigational cigarettes with three different nicotine contents (15.8 mg/gram of tobacco, 2.5 mg/g, and .4 mg/g) will be assessed. Following the third fixed-dose session, participants will return to the lab to choose one of the cigarettes to self-administer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC, INC, VLNC | Experimental | Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC) |
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| NNC, VLNC, INC | Experimental | Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content |
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| INC, VLNC, NNC | Experimental | Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content |
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| INC, NNC, VLNC | Experimental | Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content |
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| VLNC, NNC, INC | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very Low Nicotine Content Cigarettes | Other | cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective reactions to fixed doses of tobacco smoke | Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes | Immediately after puff administration of each study cigarette |
| Cigarette choice | Participants will choose which of the three cigarettes they prefer to smoke by ranking each of the three cigarette conditions using a 1-3 scale where 1 is the cigarette that they most desire to smoke and 3 is the cigarette that they least desire to smoke. | 30 minutes after sampling all 3 study cigarettes |
| Measure | Description | Time Frame |
|---|---|---|
| Mood and Affect | The Positive and Negative Affect Schedule (PANAS) | Immediately after puff administration of each study cigarette |
| Mood and Affect | Minnesota Nicotine Withdrawal Scale (MNWS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis J McClernon, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | 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 |
|---|---|
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content
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| VLNC, INC, NNC | Experimental | Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content |
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| Intermediate Nicotine Content Cigarettes | Other | cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield |
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| Normal Nicotine Content Cigarettes | Other | cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield |
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| Immediately after puff administration of each study cigarette |
| Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration | CO values (in ppm) will be obtained using a handheld CO monitor prior to puff administration and 5 minutes after completion of cigarette puff administration. The difference in values will provide a CO boost value | Immediately after puff administration of each study cigarette |
| Smoking topography - number of puffs | number of puffs | During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes) |
| Smoking topography - interpuff interval | Interpuff interval (in seconds) will be calculated using video recordings of self-administration of chosen cigarette | During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes) |