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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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This is a randomized, open-label, crossover study designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use of the investigational products (IPs) by healthy subjects.
The study will recruit smokers of combustible cigarettes.
Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility within 45 days prior to enrollment.
Starting on Day 1, eligible smokers will be confined at the clinical site for 9 days. Subjects will participate in four separate Test Sessions for AL assessment, one for each IP. Each Test Session will last for approximately 4 hours during and following IP use. Subjects will be randomized to use one IP in each Test Session: Usual Brand (UB) combustible cigarettes, nicotine gum, and 2 Electronic Nicotine Delivery Systems (ENDS).
For approximately a day and a half prior to each respective Test Session, IP will be dispensed for ad libitum use for product familiarization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product usage order ABCD | Experimental | Subjects will use each of the 4 products (ABCD) sequentially for 1 and 1/2 days during a 9 day confinement, followed by a 4 hour Test Session. |
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| Product usage order BDAC | Experimental | Subjects will use each of the 4 products (BDAC) sequentially for 1 and 1/2 days during a 9 day confinement, followed by a 4 hour Test Session. |
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| Product usage order CADB | Experimental | Subjects will use each of the 4 products (CADB) sequentially for 1 and 1/2 days during a 9 day confinement, followed by a 4 hour Test Session. |
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| Product usage order DCBA | Experimental | Subjects will use each of the 4 products (DCBA) sequentially for 1 and 1/2 days during a 9 day confinement, followed by a 4 hour Test Session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Product A | Other | Usual Brand, filtered combustible cigarette |
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| Measure | Description | Time Frame |
|---|---|---|
| AUECPL 10-240 | Area under the product liking (PL) NRS score-versus-time curve from 10 minutes to 240 minutes after the start of investigational product (IP) use. | 3, 5, 10, 15, 30, 45, 60, 90, 180, and 240 minutes |
| Emax PL | Maximum response for product effects with regards to PL score after the start of IP use. | 3, 5, 10, 15, 30, 45, 60, 90, 180, and 240 minutes |
| Eoverall IUA | Overall intent to use again (IUA), measured at 240 minutes after the start of IP use. | 240 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Hong, MD | RAIS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Orleans Center for Clinical Research (NOCCR) | Knoxville | Tennessee | 37920 | United States | ||
| ICON Clinical Research |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C476054 | HTR3D protein, human |
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| Product B | Other | CSD1902-11, an electronic nicotine delivery system |
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| Product C | Other | CSD1902-21, an electronic nicotine delivery system |
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| Product D | Other | 4mg Nicotine gum |
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| San Antonio |
| Texas |
| 78209 |
| United States |