NCT03463837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2018

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2018

Completed
Last Updated

June 21, 2021

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

March 7, 2018

Last Update Submit

June 15, 2021

Conditions

Nicotine Dependence, Other Tobacco ProductTobacco UseSmoking, Tobacco

Outcome Measures

Primary Outcomes (1)

  • 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)

    [Time Frame: 5 days]

Secondary Outcomes (19)

  • Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine

    [Time Frame: 5 days]

  • Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) in urine

    [Time Frame: 5 days]

  • Change in concentration of 1-hydroxypyrene (1-OHP) in urine

    [Time Frame: 5 days]

  • Change in concentration of Nicotine in urine

    [Time Frame: 5 days]

  • Change in concentration of Cotinine in urine

    [Time Frame: 5 days]

  • +14 more secondary outcomes

Study Arms (6)

Treatment with JUUL 5%, Virginia Tobacco

EXPERIMENTAL

JUUL 5%,Virginia Tobacco \[5 days\] in confinement.

Other: Treatment with JUUL 5%, Virginia Tobacco

Treatment with JUUL 5%, Cool Mint, ENDS

EXPERIMENTAL

JUUL 5%, Cool Mint \[5 days\] in confinement.

Other: Treatment with JUUL 5%, Cool Mint, ENDS

Treatment with JUUL 5%, Mango, ENDS

EXPERIMENTAL

JUUL 5%, Mango \[5 days\] in confinement.

Other: Treatment with JUUL 5%, Mango, ENDS

JUUL 5%, Creme Bruele, ENDS

EXPERIMENTAL

JUUL 5%, Creme Bruele \[5 days\] in confinement.

Other: JUUL 5%, Creme Bruele, ENDS

Combustible cigarette

ACTIVE COMPARATOR

Exclusive use of combustible cigarette \[5 days\] in confinement.

Other: Combustible cigarette

Smoking cessation (no smoking)

SHAM COMPARATOR

Smoking cessation (no smoking).

Other: Smoking Cessation

Interventions

Treatment with JUUL 5%, Virginia TobaccoOTHER

JUUL 5%, ENDS for 5-days in confinement

Also known as: JUUL
Treatment with JUUL 5%, Virginia Tobacco
Treatment with JUUL 5%, Cool Mint, ENDSOTHER

JUUL 5%, ENDS for 5-days in confinement

Also known as: JUUL
Treatment with JUUL 5%, Cool Mint, ENDS
Treatment with JUUL 5%, Mango, ENDSOTHER

JUUL 5%, ENDS for 5-days in confinement

Also known as: JUUL
Treatment with JUUL 5%, Mango, ENDS
JUUL 5%, Creme Bruele, ENDSOTHER

JUUL 5%, ENDS for 5-days in confinement

Also known as: JUUL
JUUL 5%, Creme Bruele, ENDS
Combustible cigaretteOTHER

Exclusive use of combustible cigarette for 5 days in confinement.

Combustible cigarette
Smoking CessationOTHER

No smoking for 5-days in confinement.

Smoking cessation (no smoking)

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Lincoln, Nebraska, 68516, United States

Location

Related Publications (5)

  • 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.

    BACKGROUND

  • 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.

    PMID: 27401980RESULT

  • 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.

    PMID: 25607446RESULT

  • 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).

    RESULT

  • 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.

    PMID: 24814944RESULT

MeSH Terms

Conditions

Tobacco Use DisorderTobacco UseTobacco Smoking

Interventions

TherapeuticsMangifera indica extract

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorSmoking

Study Officials

  • Philip Mathew, M.D.

    Celerion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 13, 2018

Study Start

March 4, 2018

Primary Completion

July 27, 2018

Study Completion

August 13, 2018

Last Updated

June 21, 2021

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)