ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 41 of 121 for:    Recruiting, Not yet recruiting, Available Studies | "Tobacco Use Disorder"

Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers (Diamond)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03463837
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Celerion
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence, Other Tobacco Product Tobacco Use Smoking, Tobacco Device: Treatment with JUUL 5%, Virginia Tobacco Device: Treatment with JUUL 5%, Cool Mint, ENDS Device: Treatment with JUUL 5%, Mango, ENDS Device: JUUL 5%, Creme Bruele, ENDS Other: Combustible cigarette Other: Smoking Cessation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : March 4, 2018
Estimated Primary Completion Date : June 21, 2018
Estimated Study Completion Date : July 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Treatment with JUUL 5%, Virginia Tobacco
JUUL 5%,Virginia Tobacco [5 days] in confinement.
Device: Treatment with JUUL 5%, Virginia Tobacco
JUUL 5%, ENDS for 5-days in confinement
Other Name: JUUL

Experimental: Treatment with JUUL 5%, Cool Mint, ENDS
JUUL 5%, Cool Mint [5 days] in confinement.
Device: Treatment with JUUL 5%, Cool Mint, ENDS
JUUL 5%, ENDS for 5-days in confinement
Other Name: JUUL

Experimental: Treatment with JUUL 5%, Mango, ENDS
JUUL 5%, Mango [5 days] in confinement.
Device: Treatment with JUUL 5%, Mango, ENDS
JUUL 5%, ENDS for 5-days in confinement
Other Name: JUUL

Experimental: JUUL 5%, Creme Bruele, ENDS
JUUL 5%, Creme Bruele [5 days] in confinement.
Device: JUUL 5%, Creme Bruele, ENDS
JUUL 5%, ENDS for 5-days in confinement
Other Name: JUUL

Active Comparator: Combustible cigarette
Exclusive use of combustible cigarette [5 days] in confinement.
Other: Combustible cigarette
Exclusive use of combustible cigarette for 5 days in confinement.

Sham Comparator: Smoking cessation (no smoking)
Smoking cessation (no smoking).
Other: Smoking Cessation
No smoking for 5-days in confinement.




Primary Outcome Measures :
  1. Change in primary biomarkers day 5 values for each JUUL 5% product will be compared to baseline: [ Time Frame: [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 :
  1. Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine [ Time Frame: [Time Frame: 5 days] ]
    Change in Biomarker

  2. Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) in urine [ Time Frame: [Time Frame: 5 days] ]
    Change in Biomarker

  3. Change in concentration of 1-hydroxypyrene (1-OHP) in urine [ Time Frame: [Time Frame: 5 days] ]
    Change in Biomarker

  4. Change in concentration of Nicotine in urine [ Time Frame: [Time Frame: 5 days] ]
    Change in Biomarker

  5. Change in concentration of Cotinine in urine [ Time Frame: [Time Frame: 5 days] ]
    Change in Biomarker

  6. Change in concentration of trans-3'-hydroxycotinine in urine [ Time Frame: [Time Frame: 5 days] ]
    Change in Biomarker

  7. Change in concentration of Glucuronides in urine [ Time Frame: [Time Frame: 5 days] ]
    Change in Biomarker

  8. Change in concentration of Nicotine in blood [ Time Frame: [Time Frame: 5 days] ]
    Change in Biomarker

  9. Change in concentration of Cotinine in blood [ Time Frame: [Time Frame: 5 days] ]
    Change in Biomarker

  10. Change in concentration of trans-3'-hydroxycotinine in blood [ Time Frame: [Time Frame: 5 days ]
    Change in Biomarker

  11. Change in maximum concentration (Cmax) Plasma pharmacokinetic (PK) of Nicotine [ Time Frame: [Time Frame: Day 7, ]
    Nicotine absorption

  12. Change in time to maximum concentration (Tmax) Plasma PK of Nicotine [ Time Frame: [Time Frame: Day 7, ]
    Nicotine absorption

  13. Change of area under the curve (AUC) Plasma PK of Nicotine [ Time Frame: [Time Frame: Day 7, ]
    Nicotine absorption

  14. Product use over 5-day period and during 5-minute fixed and ad libitum use episodes [ Time Frame: [Time Frame: 7 days] ]
    Change in product use

  15. Measure of subjective Smoking Urge Assessment [ Time Frame: [Time Frame: 6-7 days, intervention dependent] ]
    Change in Assessment

  16. Measure of subjective product evaluation using the "modified Product Evaluation Scale (mPES)" [ Time Frame: [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.


  17. Measure of future intent to use JUUL 5% Device device relative to usual combustible cigarette and smoking cessation. [ Time Frame: [Time Frame: 6-7 days, intervention dependent] ]
    Change in Intent

  18. Number of participants with Adverse Events associated with use of JUUL 5% Device to combustible cigarette and smoking cessation [ Time Frame: [Time Frame: 13-14 days, intervention dependent] ]
    Safety

  19. Incidence of JUUL 5% Device, including malfunction and/or misuse [ Time Frame: [Time Frame: 7 days] ]
    Device performance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463837


Contacts
Contact: Concetta Carbonaro 415-855-5565 concetta@juul.com
Contact: Ziad Rouag 415-531-4647 ziad@juul.com

Locations
United States, Nebraska
Celerion Recruiting
Lincoln, Nebraska, United States, 68502
Contact: Steve Hambek    402-476-2811    steve.hambek@celerion.com   
Contact: Andrea Stukel    602 437 5909    andrea.stukel@celerion.com   
Sponsors and Collaborators
Juul Labs, Inc.
Celerion
Investigators
Principal Investigator: Philip Mathew, M.D. Celerion

Publications of Results:
Other Publications:
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.

Responsible Party: Juul Labs, Inc.
ClinicalTrials.gov Identifier: NCT03463837     History of Changes
Other Study ID Numbers: JUUL-JUUL-CTP-001(755-00041)
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action