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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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The JUUL 5% Electronic Nicotine Delivery System (ENDS) is being studied as an alternative to combustible cigarette use. This study aims to find out how much nicotine is in the blood and urine of healthy adult subjects after using three JUUL 5% ENDS compared to smoking usual brands of combustible cigarettes and stopping smoking.
This study will serve as a clinical evaluation of the exclusive use of selected JUUL ENDS, with the purpose of gaining an understanding of toxicant exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with JUUL 5%, Virginia Tobacco | Experimental | JUUL 5%,Virginia Tobacco [5 days] in confinement. |
|
| Treatment with JUUL 5%, Cool Mint, ENDS | Experimental | JUUL 5%, Cool Mint [5 days] in confinement. |
|
| Treatment with JUUL 5%, Mango, ENDS | Experimental | JUUL 5%, Mango [5 days] in confinement. |
|
| JUUL 5%, Creme Bruele, ENDS | Experimental | JUUL 5%, Creme Bruele [5 days] in confinement. |
|
| Combustible cigarette | Active Comparator | Exclusive use of combustible cigarette [5 days] in confinement. |
|
| Smoking cessation (no smoking) | Sham Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with JUUL 5%, Virginia Tobacco | Other | JUUL 5%, ENDS for 5-days in confinement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in primary biomarkers day 5 values for each JUUL 5% product will be compared to baseline: | Change in ; Urine N nitrosonornicotine (NNN), 4 (methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), 3 hydroxypropylmercapturic acid (3-HPMA), monohydroxybutenylmercapturic acid (MHBMA), and S-phenyl mercapturic acid (S-PMA) "Blood carboxyhemoglobin (COHb) | [Time Frame: 5 days] |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine | Change in Biomarker | [Time Frame: 5 days] |
| Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) in urine |
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Key Inclusion Criteria:
Key Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Philip Mathew, M.D. | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | HIPAA Privacy Rule. Information for Researchers. De-identifying Protected Health Information Under the Privacy Rule. U.S. Department of Health and Human Services. NIH (Feb 2007). Available at: http://privacyruleandresearch.nih.gov/pr_08.asp#8a. Last accessed 31-Jul-2017. | ||
| 27401980 | Result | D'Ruiz CD, Graff DW, Robinson E. Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes. BMC Public Health. 2016 Jul 11;16:543. doi: 10.1186/s12889-016-3236-1. | |
| 25607446 |
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Smoking cessation (no smoking).
|
| Treatment with JUUL 5%, Cool Mint, ENDS | Other | JUUL 5%, ENDS for 5-days in confinement |
|
|
| Treatment with JUUL 5%, Mango, ENDS | Other | JUUL 5%, ENDS for 5-days in confinement |
|
|
| JUUL 5%, Creme Bruele, ENDS | Other | JUUL 5%, ENDS for 5-days in confinement |
|
|
| Combustible cigarette | Other | Exclusive use of combustible cigarette for 5 days in confinement. |
|
| Smoking Cessation | Other | No smoking for 5-days in confinement. |
|
Change in Biomarker
| [Time Frame: 5 days] |
| Change in concentration of 1-hydroxypyrene (1-OHP) in urine | Change in Biomarker | [Time Frame: 5 days] |
| Change in concentration of Nicotine in urine | Change in Biomarker | [Time Frame: 5 days] |
| Change in concentration of Cotinine in urine | Change in Biomarker | [Time Frame: 5 days] |
| Change in concentration of trans-3'-hydroxycotinine in urine | Change in Biomarker | [Time Frame: 5 days] |
| Change in concentration of Glucuronides in urine | Change in Biomarker | [Time Frame: 5 days] |
| Change in concentration of Nicotine in blood | Change in Biomarker | [Time Frame: 5 days] |
| Change in concentration of Cotinine in blood | Change in Biomarker | [Time Frame: 5 days] |
| Change in concentration of trans-3'-hydroxycotinine in blood | Change in Biomarker | [Time Frame: 5 days |
| Change in maximum concentration (Cmax) Plasma pharmacokinetic (PK) of Nicotine | Nicotine absorption | [Time Frame: Day 7, |
| Change in time to maximum concentration (Tmax) Plasma PK of Nicotine | Nicotine absorption | [Time Frame: Day 7, |
| Change of area under the curve (AUC) Plasma PK of Nicotine | Nicotine absorption | [Time Frame: Day 7, |
| Product use over 5-day period and during 5-minute fixed and ad libitum use episodes | Change in product use | [Time Frame: 7 days] |
| Measure of subjective Smoking Urge Assessment | Change in Assessment | [Time Frame: 6-7 days, intervention dependent] |
| Measure of subjective product evaluation using the "modified Product Evaluation Scale (mPES)" | Change in Evaluation; Scale: 1 = not at all, 2 = very little, 3 = a little, 4 = moderately, 5 = a lot, 6 = quite a lot, 7 = extremely Four multi-item subscales will be derived from "Satisfaction" (items 1, 2, 3, and 12); "Psychological Reward" (items 4 through 8); "Aversion" (items 9, 10, 16, and 18); and "Relief" (item 11, 13, 14, 15, and reversed for item 19) and single items 17 and 20 will be summarized. | [Time Frame: 6-7 days, intervention dependent] |
| Measure of future intent to use JUUL 5% Device device relative to usual combustible cigarette and smoking cessation. | Change in Intent | [Time Frame: 6-7 days, intervention dependent] |
| Number of participants with Adverse Events associated with use of JUUL 5% Device to combustible cigarette and smoking cessation | Safety | [Time Frame: 13-14 days, intervention dependent] |
| Incidence of JUUL 5% Device, including malfunction and/or misuse | Device performance | [Time Frame: 7 days] |
| Result |
| Jensen RP, Luo W, Pankow JF, Strongin RM, Peyton DH. Hidden formaldehyde in e-cigarette aerosols. N Engl J Med. 2015 Jan 22;372(4):392-4. doi: 10.1056/NEJMc1413069. No abstract available. |
| Result | McNeill A et al. E-cigarettes: An Evidence Update. A report commissioned by Public Health England. Available at: https://www.gov.uk/government/uploads/system/uploads/ attachment_data/file/457102/Ecigarettes_an_evidence_update_A_report_commissioned_by_ Public_Health_England_FINAL.pdf (Aug 2015). |
| 24814944 | Result | Polosa R, Morjaria J, Caponnetto P, Caruso M, Strano S, Battaglia E, Russo C. Effect of smoking abstinence and reduction in asthmatic smokers switching to electronic cigarettes: evidence for harm reversal. Int J Environ Res Public Health. 2014 May 8;11(5):4965-77. doi: 10.3390/ijerph110504965. |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D064424 | Tobacco Use |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D012907 | Smoking |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| C501277 | Mangifera indica extract |
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