Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers
- Conditions
- Nicotine Dependence, Other Tobacco ProductSmoking, TobaccoTobacco Use
- Interventions
- Other: Treatment with JUUL 5%, Virginia TobaccoOther: Treatment with JUUL 5%, Cool Mint, ENDSOther: Smoking CessationOther: Combustible cigaretteOther: JUUL 5%, Creme Bruele, ENDSOther: Treatment with JUUL 5%, Mango, ENDS
- Registration Number
- NCT03463837
- Lead Sponsor
- Juul Labs, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Healthy, adult, male or female smoker, 21 to 65 years of age.
- Has been a smoker for at least 12 months prior to Screening.
- Currently smokes an average of 10 cigarettes each day.
- Has a positive urine cotinine (≥ 500 ng/mL).
- Has an exhaled carbon monoxide (CO) > 12 ppm.
- A female subject of childbearing potential must have been using contraception and agree to continue using it through completion of the study:
- Provides voluntary consent to participate in this study documented on the signed informed consent form (ICF).
Key Exclusion Criteria
- Has a history or presence of clinically significant conditions.
- Has a body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screen
- Has a history of drug or alcohol abuse
- Has an estimated creatinine clearance < 80 mL/minute
- If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.
- Has used nicotine-containing products other than manufactured cigarettes within 14days of screening.
- Is planning to quit smoking during the study, planning to quit within 3 months following Day 1
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment with JUUL 5%, Virginia Tobacco Treatment with JUUL 5%, Virginia Tobacco JUUL 5%,Virginia Tobacco \[5 days\] in confinement. Treatment with JUUL 5%, Cool Mint, ENDS Treatment with JUUL 5%, Cool Mint, ENDS JUUL 5%, Cool Mint \[5 days\] in confinement. Smoking cessation (no smoking) Smoking Cessation Smoking cessation (no smoking). Combustible cigarette Combustible cigarette Exclusive use of combustible cigarette \[5 days\] in confinement. JUUL 5%, Creme Bruele, ENDS JUUL 5%, Creme Bruele, ENDS JUUL 5%, Creme Bruele \[5 days\] in confinement. Treatment with JUUL 5%, Mango, ENDS Treatment with JUUL 5%, Mango, ENDS JUUL 5%, Mango \[5 days\] in confinement.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in concentration of Nicotine in blood [Time Frame: 5 days] Change in Biomarker
Change of area under the curve (AUC) Plasma PK of Nicotine [Time Frame: Day 7, Nicotine absorption
Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine [Time Frame: 5 days] Change in Biomarker
Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) 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 maximum concentration (Cmax) Plasma pharmacokinetic (PK) of Nicotine [Time Frame: Day 7, Nicotine absorption
Change in concentration of Cotinine 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 blood [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 time to maximum concentration (Tmax) Plasma PK of Nicotine [Time Frame: Day 7, Nicotine absorption
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
Change in concentration of trans-3'-hydroxycotinine in blood [Time Frame: 5 days Change in Biomarker
Incidence of JUUL 5% Device, including malfunction and/or misuse [Time Frame: 7 days] Device performance
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.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
Trial Locations
- Locations (1)
Celerion
🇺🇸Lincoln, Nebraska, United States