Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS

NCT04107779 | Completed

• 1 other identifier: PROT-00030
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 5

Brief Summary

A Randomized, Open Label, Parallel Group Study in Adult Smokers to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to using JUUL Electronic Nicotine Delivery Systems With Two Different Nicotine Concentrations

Conditions

Electronic Cigarette Use; Cigarette Use, Electronic; Tobacco Use; Tobacco Smoking

Keywords

Electronic Nicotine Delivery System; Combustible Cigarettes; Nicotine

Outcome Measures

Primary Outcomes (2)

• Primary biomarkers of tobacco exposure measured in urine

  Excretion of urine total NNAL, 3-HPMA, MHBMA, and S-PMA will be assessed at baseline and following a 6-day interventional period.

  6 days

• Primary biomarker of tobacco exposure measured in blood

  Exposure to carbon monoxide will be assessed through measurement of blood COHb at baseline and following a 6-day interventional period.

  6 days

Secondary Outcomes (8)

• Secondary biomarkers of tobacco exposure measured in urine

  6 days

• Subjective product assessments as measured by the Modified Product Evaluation Scale

  6 days

• Product liking as measured by the Product-Liking Questionnaire visual analog scale

  6 days

• Urge to smoke as measured by the Urge to Smoke a Cigarette Questionnaire visual analog scale

  6 days

• Likelihood of future product use as measured by the Future Intent to Use the Product Questionnaire visual analog scale

  6 days

Study Arms (11)

JUUL 5% Virginia Tobacco ENDS

EXPERIMENTAL

JUUL 5% Virginia Tobacco flavored ENDS product \[6 days\] in confinement.

Other: Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDS

JUUL 3% Virginia Tobacco ENDS

EXPERIMENTAL

JUUL 3% Virginia Tobacco flavored ENDS product \[6 days\] in confinement.

Other: Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDS

JUUL 5% Mint ENDS

EXPERIMENTAL

JUUL 5% Mint flavored ENDS product \[6 days\] in confinement.

Other: Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDS

JUUL 3% Mint ENDS

EXPERIMENTAL

JUUL 3% Mint flavored ENDS product \[6 days\] in confinement.

Other: Switch from UB of Combustible Cigarette to JUUL 3% Mint ENDS

JUUL 5% Menthol ENDS

EXPERIMENTAL

JUUL 5% Menthol flavored ENDS product \[6 days\] in confinement.

Other: Switch from UB of Combustible Cigarette to JUUL 5% Menthol ENDS

JUUL 3% Menthol ENDS

EXPERIMENTAL

JUUL 3% Menthol flavored ENDS product \[6 days\] in confinement.

Other: Switch from UB of Combustible Cigarette to JUUL 3% Menthol ENDS

JUUL 5% Mango ENDS

EXPERIMENTAL

JUUL 5% Mango flavored ENDS product \[6 days\] in confinement.

Other: Switch from UB of Combustible Cigarette to JUUL 5% Mango ENDS

JUUL 3% Mango ENDS

EXPERIMENTAL

JUUL 3% Mango flavored ENDS product \[6 days\] in confinement.

Other: Switch from UB of Combustible Cigarette to JUUL 3% Mango ENDS

Dual-use of JUUL 5% and UB of Combustible Cigarette

EXPERIMENTAL

JUUL 5% Virginia Tobacco, Mint, Menthol, or Mango flavored ENDS product and usual brand of combustible cigarette \[6 days\] in confinement.

Other: Switch to Dual-use of JUUL 5% and UB of Combustible Cigarette

UB of Combustible Cigarette

ACTIVE COMPARATOR

Usual brand combustible cigarette \[6 days\] in confinement.

Other: Usual Brand of cigarettes

Tobacco/Nicotine Abstention

OTHER

Smoking abstention (no smoking) \[6 days\] in confinement.

Other: Tobacco/Nicotine Abstention

Interventions

Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDS OTHER

JUUL 5%, ENDS for 6-days in confinement

Also known as: JUUL

JUUL 5% Virginia Tobacco ENDS

Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDS OTHER

JUUL 3%, ENDS for 6-days in confinement

JUUL 3% Virginia Tobacco ENDS

Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDS OTHER

JUUL 5%, ENDS for 6-days in confinement

JUUL 5% Mint ENDS

Switch from UB of Combustible Cigarette to JUUL 3% Mint ENDS OTHER

JUUL 3%, ENDS for 6-days in confinement

JUUL 3% Mint ENDS

Switch from UB of Combustible Cigarette to JUUL 5% Menthol ENDS OTHER

JUUL 5%, ENDS for 6-days in confinement

JUUL 5% Menthol ENDS

Switch from UB of Combustible Cigarette to JUUL 3% Menthol ENDS OTHER

JUUL 3%, ENDS for 6-days in confinement

JUUL 3% Menthol ENDS

Switch from UB of Combustible Cigarette to JUUL 5% Mango ENDS OTHER

JUUL 5%, ENDS for 6-days in confinement

JUUL 5% Mango ENDS

Switch from UB of Combustible Cigarette to JUUL 3% Mango ENDS OTHER

JUUL 3%, ENDS for 6-days in confinement

JUUL 3% Mango ENDS

Switch to Dual-use of JUUL 5% and UB of Combustible Cigarette OTHER

Combination use of JUUL 5% (Virginia Tobacco, Mint, Menthol or Mango flavored) and usual brand combustible cigarettes for 6-days in confinement

Dual-use of JUUL 5% and UB of Combustible Cigarette

Tobacco/Nicotine Abstention OTHER

No smoking for 6-days in confinement.

Tobacco/Nicotine Abstention

Usual Brand of cigarettes OTHER

Continue smoking UB for 6-days in confinement.

UB of Combustible Cigarette

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, male or female smoker, 21 to 65 years of age, inclusive, at Screening.
• Has been a smoker for at least 12 months prior to Screening. Brief periods of non-smoking (e.g., up to \~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) during the 12 months prior to Screening will be permitted at the discretion of the Investigator.
• Currently smokes an average of 10 or more king size or 100s manufactured combustible cigarettes per day, as reported at Screening.
• Cigarettes are the only tobacco product used within (≤) 30 days prior to Screening.
• Has a positive urine cotinine (≥ 200 ng/mL) at Screening.
• Has an exhaled CO \> 10 ppm at Screening.
• A female subject of childbearing potential must have been using 1 of the following forms of contraception and agree to continue using it through completion of the study:
• hormonal (e.g., oral, vaginal ring, transdermal patch, implant, or injection) consistently for at least 3 months prior to Day -2 (Check-in);
• double barrier method (e.g., condom with spermicide, diaphragm with spermicide) consistently for at least 14 days prior to Day -2 (Check-in);
• intrauterine device for at least 3 months prior to Day -2 (Check-in);
• a partner who has been vasectomized for at least 6 months prior to Day -2 (Check-in);
• abstinence beginning at least 14 days prior to Day -2 (Check-in).
• A female subject of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Day -2 (Check-in):
• hysteroscopic sterilization;
• bilateral tubal ligation or bilateral salpingectomy;

You may not qualify if:

• Has a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of the Investigator.
• Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).
• Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment (including over-the-counter (OTC) remedies) within 14 days prior to Day -2 (Check-in).
• Has a fever (\> 100.5°F) at Screening or Day -2 (Check-in).
• Has used prescription or OTC bronchodilator medication (e.g. inhaled or oral βadrenergic agonists) to treat a chronic condition within the 12 months prior to admission;
• Currently has or recently had a bladder or urinary tract infection within 30 days prior to Check-In (Day -2).
• Has a body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening.
• Has a history of drug or alcohol abuse within 24 months prior to Day -2 (Check-in), as determined by the Investigator
• Has diabetes mellitus, asthma, or chronic obstructive pulmonary disease (COPD).
• Has a systolic blood pressure \< 90 mmHg or \> 150 mmHg, diastolic blood pressure \< 40 mmHg or \> 95 mmHg, or heart rate \< 40 bpm or \> 99 bpm at Screening.
• Has a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio \< 0.7 and FEV1 \< 80% of predicted at Screening.
• Has a post-bronchodilator FEV1 increase \> 12% and \> 200 mL from pre- to post-bronchodilator at Screening.
• Has experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the JUUL liquids (benzoic acid, propylene glycol and glycerol).
• Has an estimated creatinine clearance \< 70 mL/minute (using the Cockcroft-Gault equation) at Screening.

Sponsors & Collaborators

• Juul Labs, Inc.: lead

Study Sites (5)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

St. Louis Clinical Trials

St Louis, Missouri, 63141, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

Related Publications (11)

• Wang TW, Asman K, Gentzke AS, Cullen KA, Holder-Hayes E, Reyes-Guzman C, Jamal A, Neff L, King BA. Tobacco Product Use Among Adults - United States, 2017. MMWR Morb Mortal Wkly Rep. 2018 Nov 9;67(44):1225-1232. doi: 10.15585/mmwr.mm6744a2.

  PMID: 30408019 BACKGROUND

• U. S. Department of Health and Human Services. The health consequences of smoking - 50 years of progress: A report of the Surgeon General. Department of Health and Human Services, Public Health Service, Office of the Surgeon General. U. S. Government Printing Office, Washington, D. C. (2014)

  BACKGROUND

• Babb S, Malarcher A, Schauer G, Asman K, Jamal A. Quitting Smoking Among Adults - United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017 Jan 6;65(52):1457-1464. doi: 10.15585/mmwr.mm6552a1.

  PMID: 28056007 BACKGROUND

• Gottlieb S, Zeller M. A Nicotine-Focused Framework for Public Health. N Engl J Med. 2017 Sep 21;377(12):1111-1114. doi: 10.1056/NEJMp1707409. Epub 2017 Aug 16. No abstract available.

  PMID: 28813211 BACKGROUND

• 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: 25607446 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: 27401980 BACKGROUND

• 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).

  BACKGROUND

• 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: 24814944 BACKGROUND

• Tanner JA, Tyndale RF. Variation in CYP2A6 Activity and Personalized Medicine. J Pers Med. 2017 Dec 1;7(4):18. doi: 10.3390/jpm7040018.

  PMID: 29194389 BACKGROUND

• 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.

  BACKGROUND

• Fagerstrom K. Determinants of tobacco use and renaming the FTND to the Fagerstrom Test for Cigarette Dependence. Nicotine Tob Res. 2012 Jan;14(1):75-8. doi: 10.1093/ntr/ntr137. Epub 2011 Oct 24. No abstract available.

  PMID: 22025545 BACKGROUND

MeSH Terms

Conditions

Vaping; Tobacco Use; Tobacco Smoking

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mark Rubinstein, MD

  Juul Labs, Inc.

  STUDY DIRECTOR

Study Design

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

Model Details: Randomized, Open-Label, Parallel-Group

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 27, 2019
• Study Start: September 17, 2019
• Primary Completion: February 17, 2020
• Study Completion: June 24, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)