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| Name | Class |
|---|---|
| Rose Research Center, LLC | INDUSTRY |
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A Study to Characterize Puff Topography with Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
This will be an open label study to evaluate puff topography in adult smokers using a JUUL 5% ENDS. Up to 30 subjects will be enrolled and evaluated on Day 1 and Day 15. The duration of the study is 15 days with up to a 28 days screening window.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUUL 5%, Virginia Tobacco, ENDS product | Experimental | Subjects participate in a 15 day product use period during which subjects will be requested to predominantly use the JUUL 5% product ad libitum as their primary source of nicotine. Subjects will be asked to report their daily use of the JUUL 5% product and combustibles per day (CPD) throughout the 15 day product use period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUUL 5%, Virginia Tobacco, ENDS product | Other | Subjects participate in a 15 day product use period during which subjects will be requested to predominantly use the JUUL 5% product ad libitum as their primary source of nicotine. Subjects will be asked to report their daily use of the JUUL 5% product and CPD throughout the 15 day product use period. |
| Measure | Description | Time Frame |
|---|---|---|
| Puff Topography Parameter - Puff Duration | To characterize overall puff duration | 15 days |
| Puff Topography Parameter - Puff Volume | To characterize overall puff volume | 15 days |
| Puff Topography Parameter - Peak Puff Flow Rate | To characterize overall peak puff flow rate | 15 days |
| Puff Topography Parameter - Average Puff Flow Rate | To characterize overall average puff flow | 15 days |
| Puff Topography Parameter - Inter-Puff Interval | To characterize overall inter-puff interval (time between puffs) | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported product use over 15-day period | To assess the relationship between puff topography parameters and self-reported product use (number of puffs per day and number of JUULpods started each day) in a 15-day product use period. | 15 days |
| Subjective measure of product liking |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jed Rose, MD | Rose Research Center, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rose Research Center Charlotte | Charlotte | North Carolina | 28262 | United States | ||
| Rose Research Center Raleigh |
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To assess the relationship between puff topography parameters and JUUL 5% ENDs liking using a "Product Liking Questionnaire". Visual analogue scale with scale 0 (Not at all) to 100 (Extremely) in response to question "I like using the JUUL Product." |
| 15 days |
| Subjective measure of cigarette dependence | Assessment of cigarette dependence with "Fagerstrom Test for Cigarette Dependence Questionnaire (FTCD)". Questionnaire consists of 6 questions. | 15 days |
| Subjective measure of smoking urges | Assessment of current smoking urge with "Questionnaire of Smoking Urges - Brief (QAU-B)". Responses to various statements with scale 1 (Strongly Disagree) to 7 (Strongly Agree). | 15 days |
| Subjective measure of effects of nicotine | Assessment of nicotine using the "Direct Effects of Nicotine Scale." Visual analogue scale with scale 0 (Not at All) to 100 (Extremely) in response to words describing how the subject feels. | 15 days |
| Subject measure of affect | Assessment of affect using the "Positive and Negative Affect Scale (PANAS)". Scale consists of a number of words that describe different feelings and emotions. Scale 1 (Very Slightly or Not at All), 2 (A Little), 3 (Moderately), 4 (Quite a Bit), 5 (Extremely). | 15 days |
| Subjective measure of nicotine withdrawal | Assessment of nicotine withdrawal using the "Nicotine Withdrawal Scale (MNWS-R)." Scale consists of 15 words/statements that describe different feelings. Scale 0 (None) to 4 (Severe). | 15 days |
| Raleigh |
| North Carolina |
| 27617 |
| United States |
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D014029 | Tobacco Use Disorder |
| D000073869 | Tobacco Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012907 | Smoking |
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