Nicotine Dependence, Other Tobacco Product, Smoking, Tobacco, Tobacco Use
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERTreatment with JUUL 5%, Virginia Tobacco
JUUL 5%, ENDS for 5-days in confinement
OTHERTreatment with JUUL 5%, Cool Mint, ENDS
JUUL 5%, ENDS for 5-days in confinement
OTHERTreatment with JUUL 5%, Mango, ENDS
JUUL 5%, ENDS for 5-days in confinement
OTHERJUUL 5%, Creme Bruele, ENDS
JUUL 5%, ENDS for 5-days in confinement
Exclusive use of combustible cigarette for 5 days in confinement.
OTHERSmoking Cessation
No smoking for 5-days in confinement.
Sponsors
Celerion
Juul Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Healthy, adult, male or female smoker, 21 to 65 years of age. 2. Has been a smoker for at least 12 months prior to Screening. 3. Currently smokes an average of 10 cigarettes each day. 4. Has a positive urine cotinine (≥ 500 ng/mL). 5. Has an exhaled carbon monoxide (CO) \> 12 ppm. 6. A female subject of childbearing potential must have been using contraception and agree to continue using it through completion of the study: 7. Provides voluntary consent to participate in this study documented on the signed informed consent form (ICF). Key
Exclusion criteria
1. Has a history or presence of clinically significant conditions. 2. Has a body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screen 3. Has a history of drug or alcohol abuse 4. Has an estimated creatinine clearance \< 80 mL/minute 5. If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study. 6. Has used nicotine-containing products other than manufactured cigarettes within 14days of screening. 7. Is planning to quit smoking during the study, planning to quit within 3 months following Day 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in primary biomarkers day 5 values for each JUUL 5% product will be compared to baseline: | [Time Frame: 5 days] | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) in urine | [Time Frame: 5 days] | Change in Biomarker |
| Change in concentration of 1-hydroxypyrene (1-OHP) in urine | [Time Frame: 5 days] | Change in Biomarker |
| Change in concentration of Nicotine in urine | [Time Frame: 5 days] | Change in Biomarker |
| Change in concentration of Cotinine in urine | [Time Frame: 5 days] | Change in Biomarker |
| Change in concentration of trans-3'-hydroxycotinine in urine | [Time Frame: 5 days] | Change in Biomarker |
| Change in concentration of Glucuronides in urine | [Time Frame: 5 days] | Change in Biomarker |
| Change in concentration of Nicotine in blood | [Time Frame: 5 days] | Change in Biomarker |
| Change in concentration of Cotinine in blood | [Time Frame: 5 days] | Change in Biomarker |
| Change in concentration of trans-3'-hydroxycotinine in blood | [Time Frame: 5 days | Change in Biomarker |
| Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine | [Time Frame: 5 days] | Change in Biomarker |
| Change in time to maximum concentration (Tmax) Plasma PK of Nicotine | [Time Frame: Day 7, | Nicotine absorption |
| Change of area under the curve (AUC) Plasma PK of Nicotine | [Time Frame: Day 7, | Nicotine absorption |
| Product use over 5-day period and during 5-minute fixed and ad libitum use episodes | [Time Frame: 7 days] | Change in product use |
| Measure of subjective Smoking Urge Assessment | [Time Frame: 6-7 days, intervention dependent] | Change in Assessment |
| Measure of subjective product evaluation using the modified Product Evaluation Scale (mPES) | [Time Frame: 6-7 days, intervention dependent] | 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. |
| Measure of future intent to use JUUL 5% Device device relative to usual combustible cigarette and smoking cessation. | [Time Frame: 6-7 days, intervention dependent] | Change in Intent |
| Number of participants with Adverse Events associated with use of JUUL 5% Device to combustible cigarette and smoking cessation | [Time Frame: 13-14 days, intervention dependent] | Safety |
| Incidence of JUUL 5% Device, including malfunction and/or misuse | [Time Frame: 7 days] | Device performance |
| Change in maximum concentration (Cmax) Plasma pharmacokinetic (PK) of Nicotine | [Time Frame: Day 7, | Nicotine absorption |
Countries
United States
Outcome results
None listed