Clinical trial NCT03463837: Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers
Official title: A Randomized, Open-Label, Parallel-Group Study to Characterize Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence, Other Tobacco Product
Tobacco Use
Smoking, Tobacco
Lead sponsor: Juul Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2018-03-13
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Change in primary biomarkers day 5 values for each JUUL 5% product will be compared to baseline:
timeFrame: [Time Frame: 5 days]
Secondary outcomes:
measure: Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine
timeFrame: [Time Frame: 5 days]
measure: Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) in urine
timeFrame: [Time Frame: 5 days]
measure: Change in concentration of 1-hydroxypyrene (1-OHP) in urine
timeFrame: [Time Frame: 5 days]
measure: Change in concentration of Nicotine in urine
timeFrame: [Time Frame: 5 days]
measure: Change in concentration of Cotinine in urine
timeFrame: [Time Frame: 5 days]
measure: Change in concentration of trans-3'-hydroxycotinine in urine
timeFrame: [Time Frame: 5 days]
measure: Change in concentration of Glucuronides in urine
timeFrame: [Time Frame: 5 days]
measure: Change in concentration of Nicotine in blood
timeFrame: [Time Frame: 5 days]
measure: Change in concentration of Cotinine in blood
timeFrame: [Time Frame: 5 days]
measure: Change in concentration of trans-3'-hydroxycotinine in blood
timeFrame: [Time Frame: 5 days
measure: Change in maximum concentration (Cmax) Plasma pharmacokinetic (PK) of Nicotine
timeFrame: [Time Frame: Day 7,
measure: Change in time to maximum concentration (Tmax) Plasma PK of Nicotine
timeFrame: [Time Frame: Day 7,
measure: Change of area under the curve (AUC) Plasma PK of Nicotine
timeFrame: [Time Frame: Day 7,
measure: Product use over 5-day period and during 5-minute fixed and ad libitum use episodes
timeFrame: [Time Frame: 7 days]
measure: Measure of subjective Smoking Urge Assessment
timeFrame: [Time Frame: 6-7 days, intervention dependent]
measure: Measure of subjective product evaluation using the "modified Product Evaluation Scale (mPES)"
timeFrame: [Time Frame: 6-7 days, intervention dependent]
measure: Measure of future intent to use JUUL 5% Device device relative to usual combustible cigarette and smoking cessation.
timeFrame: [Time Frame: 6-7 days, intervention dependent]
measure: Number of participants with Adverse Events associated with use of JUUL 5% Device to combustible cigarette and smoking cessation
timeFrame: [Time Frame: 13-14 days, intervention dependent]
measure: Incidence of JUUL 5% Device, including malfunction and/or misuse
timeFrame: [Time Frame: 7 days]
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Celerion
name: Philip Mathew, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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).
citation: 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.