Electronic Cigarette UseNCT04107779

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

A study testing Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDS, Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDS and Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDS in people with Electronic Cigarette Use and Cigarette Use, Electronic, run by Juul Labs, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Electronic Cigarette Use, Cigarette Use, Electronic, Tobacco Use
What is being tested?: Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDS, Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDS and Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 279 participants
Where: 5 sitesUnited States
Study dates: 17 Sep 2019to 24 Jun 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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;
hysterectomy;
bilateral oophorectomy;
Or be postmenopausal with amenorrhea for at least 1 year prior to Day -2 (Check-in) and follicle-stimulating hormone (FSH) levels consistent with postmenopausal status.
Is willing to comply with the requirements of the study, including a willingness to exclusively use the JUUL products or stop smoking for the duration of the study.
Provides voluntary consent to participate in this study documented on the signed informed consent form (ICF).

Who cannot join

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;

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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.
Has a positive urine screen for drugs of abuse or positive urine/breath screen for alcohol at Screening or Day -2 (Check-in).
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 medications known to interact with cytochrome P450 (CYP) 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital, selegiline, sulconazole, tioconazole, tranylcypromine) within 14 days or 5 half-lives of the drug, whichever is longer, prior to Day -2 (Check-in).
Has used nicotine-containing products other than manufactured cigarettes (e.g., ENDS, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, hookah/shisha, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 30 days prior to Day -2 (Check-in), except as required per protocol (e.g., the brief product trial at Screening).
Has a prior history of JUUL product use within (≤) 30 days prior to Screening.
Has used any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Day -2 (Check-in).
Is a self-reported puffer (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
Is planning to quit smoking during the study or within 3 months following Day 1, or is postponing a quit attempt in order to participate in the study.
Negative response (i.e., unwilling to use or unable to tolerate [e.g., experiences Adverse Events during the product trial that will prevent the subjects from continuing to use the JUUL product as judged by the Investigator]) to any of the JUUL products at Screening.
Has donated plasma within 7 days prior to Day -2 (Check-in).
Has donated blood or blood products (with the exception of plasma as noted above), has had significant blood loss, or received whole blood or a blood product transfusion within 3 months prior to Day -2 (Check-in).
Has taken any multivitamin, fish oil or biotin supplements within 48 hours prior to Check-in (Day -2).
Has consumed any cured meats (e.g., bacon, ham, sausage, corned beef, jerky) or meats cooked at high temperatures (e.g., grilled, fried, smoked or barbecued) within 2 days prior to Check-in (Day -2).
Has consumed any grapefruit (including grapefruit juice) eggplant or cruciferous vegetables (e.g., cauliflower, cabbage, kale, garden cress, bok choy, broccoli, brussels sprouts and similar green leaf vegetables) within 48 hours prior to Check-in (Day -2).
Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Day -2 (Check-in).
Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee of any of the study sites.
Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee, shareholder, or is member of the board of directors of JUUL Labs Inc.
Has previously taken part in, been withdrawn from, or has completed this study.
Has previously been diagnosed with any form of cancer, except for basal cell or squamous epithelial carcinomas of the skin that have been resected at least 1 year prior to Screening.
In the opinion of the Investigator, the subject should not participate in this study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Midwest Clinical Research Center
Dayton, Ohio, 45417
Woodland International Research Group
Little Rock, Arkansas, 72211
Woodland Research Northwest
Rogers, Arkansas, 72758
Endeavor Clinical Trials
San Antonio, Texas, 78229
St. Louis Clinical Trials
St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: 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

Read the detailed description

Previous studies and data reported in the literature support that Electronic Nicotine Delivery Systems (ENDS) have less toxicant exposure. This study will serve as a clinical evaluation of exclusive-use of selected JUUL ENDS in 2 different nicotine concentrations (5%, 3%), with the purpose of gaining data to support the hypothesis that exclusive-use of JUUL ENDS over the course of 6 days will result in a significant reduction in toxicant exposure compared to combustible cigarettes.

This will be a randomized, open label, parallel group study in adult smokers to be conducted at up to 5 sites in the United States. Changes in Biomarkers of Exposure (BoEs) from baseline when using four JUUL ENDS with 2 different nicotine concentrations (5%, 3%) relative to Usual Brand (UB) of combustible cigarettes and a study group abstaining from any tobacco/nicotine product use will be assessed in this study. JUUL ENDS will be used either exclusively or partially (dual-use), with subjects in the dual-use group using both JUUL 5% ENDS (choice of Virginia Tobacco (VT), Mint, Menthol or Mango flavors) and UB of combustible cigarettes.

Conditions: Electronic Cigarette Use, Cigarette Use, Electronic, Tobacco Use, Tobacco Smoking
Being tested: Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDS, Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDS, Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDS, Switch from UB of Combustible Cigarette to JUUL 3% Mint ENDS, Switch from UB of Combustible Cigarette to JUUL 5% Menthol ENDS
Keywords: Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine
Medical subject headings: Vaping, Tobacco Use, Tobacco Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDSOther
Also called JUUL
JUUL 5%, ENDS for 6-days in confinement
Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDSOther
JUUL 3%, ENDS for 6-days in confinement
Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDSOther
JUUL 5%, ENDS for 6-days in confinement
Switch from UB of Combustible Cigarette to JUUL 3% Mint ENDSOther
JUUL 3%, ENDS for 6-days in confinement
Switch from UB of Combustible Cigarette to JUUL 5% Menthol ENDSOther
JUUL 5%, ENDS for 6-days in confinement
Switch from UB of Combustible Cigarette to JUUL 3% Menthol ENDSOther
JUUL 3%, ENDS for 6-days in confinement
Switch from UB of Combustible Cigarette to JUUL 5% Mango ENDSOther
JUUL 5%, ENDS for 6-days in confinement
Switch from UB of Combustible Cigarette to JUUL 3% Mango ENDSOther
JUUL 3%, ENDS for 6-days in confinement
Switch to Dual-use of JUUL 5% and UB of Combustible CigaretteOther
Combination use of JUUL 5% (Virginia Tobacco, Mint, Menthol or Mango flavored) and usual brand combustible cigarettes for 6-days in confinement
Tobacco/Nicotine AbstentionOther
No smoking for 6-days in confinement.
Usual Brand of cigarettesOther
Continue smoking UB for 6-days in confinement.

Study groups in NCT04107779
Study group	Role	What they receive
JUUL 5% Virginia Tobacco ENDS	Experimental	JUUL 5% Virginia Tobacco flavored ENDS product [6 days] in confinement. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Usual Brand of cigarettes
Tobacco/Nicotine Abstention	Other	Smoking abstention (no smoking) [6 days] in confinement. Receives: Other: Tobacco/Nicotine Abstention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 6 days

Secondary outcomes (8)

Secondary biomarkers of tobacco exposure measured in urine
Excretion of total NNN, total 1-OHP, O-toluidine, 2-NA, 4-ABP, and urine mutagenic activity will be assessed at baseline and following a 6-day interventional period.
Measured: 6 days
Subjective product assessments as measured by the Modified Product Evaluation Scale
Subjective product assessments as measured by responses to the Modified Product Evaluation Scale will be made at baseline and during the interventional period.
Measured: 6 days
Product liking as measured by the Product-Liking Questionnaire visual analog scale
The degree to which subjects like the product will be assessed using the Product-Liking Questionnaire at baseline and during the interventional period.
Measured: 6 days
Urge to smoke as measured by the Urge to Smoke a Cigarette Questionnaire visual analog scale
Urge to smoke as measured by responses to the Urge to Smoke a Cigarette Questionnaire will be assessed at baseline and during the interventional period.
Measured: 6 days
Likelihood of future product use as measured by the Future Intent to Use the Product Questionnaire visual analog scale
Likelihood of future product use as measured by responses to the Future Intent to Use the Product Questionnaire will be made at baseline and during the interventional period.
Measured: 6 days
Daily JUUL product consumption
Daily consumption of the JUUL products as measured by the change in pod weight after use during the interventional period will be reported.
Measured: 6 days
Daily combustible cigarette consumption
Daily consumption of combustible cigarettes as measured by the number of cigarettes smoked per day at baseline and during the interventional period will be reported.
Measured: 6 days
Incidence of adverse events
Safety and tolerability will be assessed by monitoring the incidence of product-use emergent adverse events.
Measured: 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 201924 Jun 2020

First posted27 Sep 2019
Study start17 Sep 2019
Primary completion17 Feb 2020
Study completion24 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, Open-Label, Parallel-Group
Masking: None (open label)
Enrolment: 279 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04107779
Sponsor's protocol ID: PROT-00030
Status last verified: Jul 2020
First submitted: 24 Sep 2019
Last updated: 28 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 30408019
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)
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.
PubMed 28056007
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.
PubMed 28813211
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.
PubMed 25607446
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.
PubMed 27401980
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).
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.
PubMed 24814944
Tanner JA, Tyndale RF. Variation in CYP2A6 Activity and Personalized Medicine. J Pers Med. 2017 Dec 1;7(4):18. doi: 10.3390/jpm7040018.
PubMed 29194389
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.
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.
PubMed 22025545

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems

All Electronic Cigarette Use trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04107779
Acronym / sponsor ID: PROT-00030
Conditions: Electronic Cigarette Use, Cigarette Use, Electronic, Tobacco Use, Tobacco Smoking
Keywords: Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine
Study type: Interventional
Recruitment status: Completed
Enrolment: 279 participants (actual)
Lead sponsor: Juul Labs, Inc.Industry (pharma, biotech, devices)
Study start: 17 Sep 2019 (actual)
Primary completion: 17 Feb 2020 (actual)
Study completion: 24 Jun 2020 (actual)
First posted: 27 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 11
Model description: Randomized, Open-Label, Parallel-Group

Arm	Type	Receives
JUUL 5% Virginia Tobacco ENDS	Experimental	Other: Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDSJUUL 5% Virginia Tobacco flavored ENDS product [6 days] in confinement.
JUUL 3% Virginia Tobacco ENDS	Experimental	Other: Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDSJUUL 3% Virginia Tobacco flavored ENDS product [6 days] in confinement.
JUUL 5% Mint ENDS	Experimental	Other: Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDSJUUL 5% Mint flavored ENDS product [6 days] in confinement.
JUUL 3% Mint ENDS	Experimental	Other: Switch from UB of Combustible Cigarette to JUUL 3% Mint ENDSJUUL 3% Mint flavored ENDS product [6 days] in confinement.
JUUL 5% Menthol ENDS	Experimental	Other: Switch from UB of Combustible Cigarette to JUUL 5% Menthol ENDSJUUL 5% Menthol flavored ENDS product [6 days] in confinement.
JUUL 3% Menthol ENDS	Experimental	Other: Switch from UB of Combustible Cigarette to JUUL 3% Menthol ENDSJUUL 3% Menthol flavored ENDS product [6 days] in confinement.
JUUL 5% Mango ENDS	Experimental	Other: Switch from UB of Combustible Cigarette to JUUL 5% Mango ENDSJUUL 5% Mango flavored ENDS product [6 days] in confinement.
JUUL 3% Mango ENDS	Experimental	Other: Switch from UB of Combustible Cigarette to JUUL 3% Mango ENDSJUUL 3% Mango flavored ENDS product [6 days] in confinement.
Dual-use of JUUL 5% and UB of Combustible Cigarette	Experimental	Other: Switch to Dual-use of JUUL 5% and UB of Combustible CigaretteJUUL 5% Virginia Tobacco, Mint, Menthol, or Mango flavored ENDS product and usual brand of combustible cigarette [6 days] in confinement.
UB of Combustible Cigarette	Active comparator	Other: Usual Brand of cigarettesUsual brand combustible cigarette [6 days] in confinement.
Tobacco/Nicotine Abstention	Other	Other: Tobacco/Nicotine AbstentionSmoking abstention (no smoking) [6 days] in confinement.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

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.

Key exclusion criteria (35 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDSAlso: JUULJUUL 5%, ENDS for 6-days in confinement	Other	JUUL 5% Virginia Tobacco ENDS
Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDSJUUL 3%, ENDS for 6-days in confinement	Other	JUUL 3% Virginia Tobacco ENDS
Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDSJUUL 5%, ENDS for 6-days in confinement	Other	JUUL 5% Mint ENDS
Switch from UB of Combustible Cigarette to JUUL 3% Mint ENDSJUUL 3%, ENDS for 6-days in confinement	Other	JUUL 3% Mint ENDS
Switch from UB of Combustible Cigarette to JUUL 5% Menthol ENDSJUUL 5%, ENDS for 6-days in confinement	Other	JUUL 5% Menthol ENDS
Switch from UB of Combustible Cigarette to JUUL 3% Menthol ENDSJUUL 3%, ENDS for 6-days in confinement	Other	JUUL 3% Menthol ENDS
Switch from UB of Combustible Cigarette to JUUL 5% Mango ENDSJUUL 5%, ENDS for 6-days in confinement	Other	JUUL 5% Mango ENDS
Switch from UB of Combustible Cigarette to JUUL 3% Mango ENDSJUUL 3%, ENDS for 6-days in confinement	Other	JUUL 3% Mango ENDS
Switch to Dual-use of JUUL 5% and UB of Combustible CigaretteCombination use of JUUL 5% (Virginia Tobacco, Mint, Menthol or Mango flavored) and usual brand combustible cigarettes for 6-days in confinement	Other	Dual-use of JUUL 5% and UB of Combustible Cigarette
Tobacco/Nicotine AbstentionNo smoking for 6-days in confinement.	Other	Tobacco/Nicotine Abstention
Usual Brand of cigarettesContinue smoking UB for 6-days in confinement.	Other	UB of Combustible Cigarette

Primary outcome

Primary biomarkers of tobacco exposure measured in urine
Time frame: 6 days
Excretion of urine total NNAL, 3-HPMA, MHBMA, and S-PMA will be assessed at baseline and following a 6-day interventional period.
Primary biomarker of tobacco exposure measured in blood
Time frame: 6 days
Exposure to carbon monoxide will be assessed through measurement of blood COHb at baseline and following a 6-day interventional period.

8 secondary outcomes

Secondary biomarkers of tobacco exposure measured in urine
Time frame: 6 days
Subjective product assessments as measured by the Modified Product Evaluation Scale
Time frame: 6 days
Product liking as measured by the Product-Liking Questionnaire visual analog scale
Time frame: 6 days
Urge to smoke as measured by the Urge to Smoke a Cigarette Questionnaire visual analog scale
Time frame: 6 days
Likelihood of future product use as measured by the Future Intent to Use the Product Questionnaire visual analog scale
Time frame: 6 days
Daily JUUL product consumption
Time frame: 6 days
Daily combustible cigarette consumption
Time frame: 6 days
Incidence of adverse events
Time frame: 6 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
Background: PubMed 30408019Wang 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.
BackgroundU. 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: PubMed 28056007Babb 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.
Background: PubMed 28813211Gottlieb 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.
Background: PubMed 25607446Jensen 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.
Background: PubMed 27401980D'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.
BackgroundMcNeill 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: PubMed 24814944Polosa 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.
Background: PubMed 29194389Tanner JA, Tyndale RF. Variation in CYP2A6 Activity and Personalized Medicine. J Pers Med. 2017 Dec 1;7(4):18. doi: 10.3390/jpm7040018.
BackgroundHIPAA 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: PubMed 22025545Fagerstrom 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Rubinstein, MD study director

Juul Labs, Inc.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary biomarkers of tobacco exposure measured in urine (time frame: 6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04107779, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.