Back to resultsIdentify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers (Diamond)
Primary Purpose
Nicotine Dependence, Other Tobacco Product, Tobacco Use, Smoking, Tobacco
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment with JUUL 5%, Virginia Tobacco
Treatment with JUUL 5%, Cool Mint, ENDS
Treatment with JUUL 5%, Mango, ENDS
JUUL 5%, Creme Bruele, ENDS
Combustible cigarette
Smoking Cessation
Sponsored by
About this trial
This is an interventional other trial for Nicotine Dependence, Other Tobacco Product
Eligibility Criteria
Key Inclusion Criteria:
- 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
Sites / Locations
- Celerion
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Sham Comparator
Arm Label
Treatment with JUUL 5%, Virginia Tobacco
Treatment with JUUL 5%, Cool Mint, ENDS
Treatment with JUUL 5%, Mango, ENDS
JUUL 5%, Creme Bruele, ENDS
Combustible cigarette
Smoking cessation (no smoking)
Arm Description
JUUL 5%,Virginia Tobacco [5 days] in confinement.
JUUL 5%, Cool Mint [5 days] in confinement.
JUUL 5%, Mango [5 days] in confinement.
JUUL 5%, Creme Bruele [5 days] in confinement.
Exclusive use of combustible cigarette [5 days] in confinement.
Smoking cessation (no smoking).
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine
Change in Biomarker
Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) in urine
Change in Biomarker
Change in concentration of 1-hydroxypyrene (1-OHP) in urine
Change in Biomarker
Change in concentration of Nicotine in urine
Change in Biomarker
Change in concentration of Cotinine in urine
Change in Biomarker
Change in concentration of trans-3'-hydroxycotinine in urine
Change in Biomarker
Change in concentration of Glucuronides in urine
Change in Biomarker
Change in concentration of Nicotine in blood
Change in Biomarker
Change in concentration of Cotinine in blood
Change in Biomarker
Change in concentration of trans-3'-hydroxycotinine in blood
Change in Biomarker
Change in maximum concentration (Cmax) Plasma pharmacokinetic (PK) of Nicotine
Nicotine absorption
Change in time to maximum concentration (Tmax) Plasma PK of Nicotine
Nicotine absorption
Change of area under the curve (AUC) Plasma PK of Nicotine
Nicotine absorption
Product use over 5-day period and during 5-minute fixed and ad libitum use episodes
Change in product use
Measure of subjective Smoking Urge Assessment
Change in Assessment
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.
Measure of future intent to use JUUL 5% Device device relative to usual combustible cigarette and smoking cessation.
Change in Intent
Number of participants with Adverse Events associated with use of JUUL 5% Device to combustible cigarette and smoking cessation
Safety
Incidence of JUUL 5% Device, including malfunction and/or misuse
Device performance
Full Information
NCT ID
NCT03463837
First Posted
March 7, 2018
Last Updated
June 15, 2021
Sponsor
Juul Labs, Inc.
Collaborators
Celerion
1. Study Identification
Unique Protocol Identification Number
NCT03463837
Brief Title
Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers
Acronym
Diamond
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 4, 2018 (Actual)
Primary Completion Date
July 27, 2018 (Actual)
Study Completion Date
August 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Juul Labs, Inc.
Collaborators
Celerion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Other Tobacco Product, Tobacco Use, Smoking, Tobacco
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with JUUL 5%, Virginia Tobacco
Arm Type
Experimental
Arm Description
JUUL 5%,Virginia Tobacco [5 days] in confinement.
Arm Title
Treatment with JUUL 5%, Cool Mint, ENDS
Arm Type
Experimental
Arm Description
JUUL 5%, Cool Mint [5 days] in confinement.
Arm Title
Treatment with JUUL 5%, Mango, ENDS
Arm Type
Experimental
Arm Description
JUUL 5%, Mango [5 days] in confinement.
Arm Title
JUUL 5%, Creme Bruele, ENDS
Arm Type
Experimental
Arm Description
JUUL 5%, Creme Bruele [5 days] in confinement.
Arm Title
Combustible cigarette
Arm Type
Active Comparator
Arm Description
Exclusive use of combustible cigarette [5 days] in confinement.
Arm Title
Smoking cessation (no smoking)
Arm Type
Sham Comparator
Arm Description
Smoking cessation (no smoking).
Intervention Type
Other
Intervention Name(s)
Treatment with JUUL 5%, Virginia Tobacco
Other Intervention Name(s)
JUUL
Intervention Description
JUUL 5%, ENDS for 5-days in confinement
Intervention Type
Other
Intervention Name(s)
Treatment with JUUL 5%, Cool Mint, ENDS
Other Intervention Name(s)
JUUL
Intervention Description
JUUL 5%, ENDS for 5-days in confinement
Intervention Type
Other
Intervention Name(s)
Treatment with JUUL 5%, Mango, ENDS
Other Intervention Name(s)
JUUL
Intervention Description
JUUL 5%, ENDS for 5-days in confinement
Intervention Type
Other
Intervention Name(s)
JUUL 5%, Creme Bruele, ENDS
Other Intervention Name(s)
JUUL
Intervention Description
JUUL 5%, ENDS for 5-days in confinement
Intervention Type
Other
Intervention Name(s)
Combustible cigarette
Intervention Description
Exclusive use of combustible cigarette for 5 days in confinement.
Intervention Type
Other
Intervention Name(s)
Smoking Cessation
Intervention Description
No smoking for 5-days in confinement.
Primary Outcome Measure Information:
Title
Change in primary biomarkers day 5 values for each JUUL 5% product will be compared to baseline:
Description
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
[Time Frame: 5 days]
Secondary Outcome Measure Information:
Title
Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine
Description
Change in Biomarker
Time Frame
[Time Frame: 5 days]
Title
Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) in urine
Description
Change in Biomarker
Time Frame
[Time Frame: 5 days]
Title
Change in concentration of 1-hydroxypyrene (1-OHP) in urine
Description
Change in Biomarker
Time Frame
[Time Frame: 5 days]
Title
Change in concentration of Nicotine in urine
Description
Change in Biomarker
Time Frame
[Time Frame: 5 days]
Title
Change in concentration of Cotinine in urine
Description
Change in Biomarker
Time Frame
[Time Frame: 5 days]
Title
Change in concentration of trans-3'-hydroxycotinine in urine
Description
Change in Biomarker
Time Frame
[Time Frame: 5 days]
Title
Change in concentration of Glucuronides in urine
Description
Change in Biomarker
Time Frame
[Time Frame: 5 days]
Title
Change in concentration of Nicotine in blood
Description
Change in Biomarker
Time Frame
[Time Frame: 5 days]
Title
Change in concentration of Cotinine in blood
Description
Change in Biomarker
Time Frame
[Time Frame: 5 days]
Title
Change in concentration of trans-3'-hydroxycotinine in blood
Description
Change in Biomarker
Time Frame
[Time Frame: 5 days
Title
Change in maximum concentration (Cmax) Plasma pharmacokinetic (PK) of Nicotine
Description
Nicotine absorption
Time Frame
[Time Frame: Day 7,
Title
Change in time to maximum concentration (Tmax) Plasma PK of Nicotine
Description
Nicotine absorption
Time Frame
[Time Frame: Day 7,
Title
Change of area under the curve (AUC) Plasma PK of Nicotine
Description
Nicotine absorption
Time Frame
[Time Frame: Day 7,
Title
Product use over 5-day period and during 5-minute fixed and ad libitum use episodes
Description
Change in product use
Time Frame
[Time Frame: 7 days]
Title
Measure of subjective Smoking Urge Assessment
Description
Change in Assessment
Time Frame
[Time Frame: 6-7 days, intervention dependent]
Title
Measure of subjective product evaluation using the "modified Product Evaluation Scale (mPES)"
Description
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
[Time Frame: 6-7 days, intervention dependent]
Title
Measure of future intent to use JUUL 5% Device device relative to usual combustible cigarette and smoking cessation.
Description
Change in Intent
Time Frame
[Time Frame: 6-7 days, intervention dependent]
Title
Number of participants with Adverse Events associated with use of JUUL 5% Device to combustible cigarette and smoking cessation
Description
Safety
Time Frame
[Time Frame: 13-14 days, intervention dependent]
Title
Incidence of JUUL 5% Device, including malfunction and/or misuse
Description
Device performance
Time Frame
[Time Frame: 7 days]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Mathew, M.D.
Organizational Affiliation
Celerion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Celerion
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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.
Results Reference
background
PubMed Identifier
27401980
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.
Results Reference
result
PubMed Identifier
25607446
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.
Results Reference
result
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).
Results Reference
result
PubMed Identifier
24814944
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.
Results Reference
result
Learn more about this trial
Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers
We'll reach out to this number within 24 hrs