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Completed

NCT Number: NCT03463837

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

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.

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Key information

Conditions

Nicotine Dependence, Other Tobacco Product Behavior Chemically-Induced Disorders Mental Disorders Smoking Smoking, Tobacco Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Celerion

Lincoln, Nebraska, 68516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment with JUUL 5%, Virginia Tobacco

Other

JUUL 5%, ENDS for 5-days in confinement

Other names: JUUL

Treatment with JUUL 5%, Cool Mint, ENDS

Other

JUUL 5%, ENDS for 5-days in confinement

Other names: JUUL

Treatment with JUUL 5%, Mango, ENDS

Other

JUUL 5%, ENDS for 5-days in confinement

Other names: JUUL

JUUL 5%, Creme Bruele, ENDS

Other

JUUL 5%, ENDS for 5-days in confinement

Other names: JUUL

Combustible Cigarette

Other

Exclusive use of combustible cigarette for 5 days in confinement.

smoking cessation

Other

No smoking for 5-days in confinement.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Juul Labs, Inc.

Industry

Collaborators

  • Celerion

Registry information

Official study 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

Acronym: Diamond

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2018
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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