An interventional study of Treatment with JUUL 5%, Virginia Tobacco and Treatment with JUUL 5%, Cool Mint, ENDS in Nicotine Dependence, Other Tobacco Product, Tobacco Use and Smoking, Tobacco, sponsored by Juul Labs, Inc.. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-21.
Sponsored by Juul Labs, Inc. · Not applicable, Interventional, and Other
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Among 799 studies in Tobacco Use Disorder with a site in United States — 75 open to participants now, 91 under way, 5 of them phase 3. Tobacco Use Disorder · United States.
Among the 799 studies in Tobacco Use Disorder with a site in United States, this one is the 350th largest by enrollment of the 736 interventional ones that give a count, is one of 40 that started in 2018, is one of 364 with no phase, and was the 562nd registered.
1,028 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
Browse Tobacco Use Disorder studies →75 of the 799 studies in Tobacco Use Disorder with a site in United States are open now. Recruiting first, the newest first:
Florida International University · Sites in United States
Ages 14–18
Ohio State University Comprehensive Cancer Center · Sites in United States
Ages 21+ · Healthy volunteers
VA Office of Research and Development · Sites in United States
Ages 21+
VA Office of Research and Development · Sites in United States
Yale University · Sites in United States
Ages 21–44 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 95 Tobacco Use Disorder studies recruiting now, 42 (44%) set no upper age limit and 50 (53%) stop at 75 or younger; 6 take children under 18; 37 take healthy volunteers.
This study: 21 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
799 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 110 · Phase 2 177 · Phase 3 66 · Phase 4 71
First in 1990; this study’s year is marked. 40 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 90 is close to the median of 90 across 893 interventional studies indexed under Tobacco Use Disorder.
Median enrollment 84 across the 736 interventional studies, 112 across the 58 observational. Of the 656 that completed or were terminated, 344 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 799 have an industry lead sponsor. The 10 most frequent:
Juul Labs, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Juul Labs, Inc. has 5 studies filed under Tobacco Use Disorder — fewer than ten, so there is no comparison to draw.
40 of the studies in Tobacco Use Disorder with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04176172Phase 3Abramson Cancer Center at Penn MedicineOptimizing Tobacco Use Treatment for PLWHA | 2026-11-30 |
| NCT06837220University of ChicagoImplementation of Tobacco Cessation Programming at Community Behavioral Health Sites | 2026-12 |
| NCT05452772Johns Hopkins University5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder | 2026-12 |
| NCT07322432VapeAwayThe CONQUER Trial - Cessation Of Nicotine, QUitting With E-cigarette Reduction | 2026-12 |
| NCT06617312University of California, Los AngelesExamining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity | 2026-12 |
Add all 40 to your calendar (.ics) → With an account.
Among the 799 studies in Tobacco Use Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Key Inclusion Criteria:
Key Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
JUUL 5%,Virginia Tobacco \[5 days\] in confinement.
Other: Treatment with JUUL 5%, Virginia Tobacco
JUUL 5%, Cool Mint \[5 days\] in confinement.
Other: Treatment with JUUL 5%, Cool Mint, ENDS
JUUL 5%, Mango \[5 days\] in confinement.
Other: Treatment with JUUL 5%, Mango, ENDS
JUUL 5%, Creme Bruele \[5 days\] in confinement.
Other: JUUL 5%, Creme Bruele, ENDS
Exclusive use of combustible cigarette \[5 days\] in confinement.
Other: Combustible cigarette
Smoking cessation (no smoking).
Other: Smoking Cessation
JUUL 5%, ENDS for 5-days in confinement
Also known as: JUUL
JUUL 5%, ENDS for 5-days in confinement
Also known as: JUUL
JUUL 5%, ENDS for 5-days in confinement
Also known as: JUUL
JUUL 5%, ENDS for 5-days in confinement
Also known as: JUUL
Exclusive use of combustible cigarette for 5 days in confinement.
No smoking for 5-days in confinement.
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: [Time Frame: 5 days]
Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine
Change in Biomarker
Time frame: [Time Frame: 5 days]
Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) in urine
Change in Biomarker
Time frame: [Time Frame: 5 days]
Change in concentration of 1-hydroxypyrene (1-OHP) in urine
Change in Biomarker
Time frame: [Time Frame: 5 days]
Change in concentration of Nicotine in urine
Change in Biomarker
Time frame: [Time Frame: 5 days]
Change in concentration of Cotinine in urine
Change in Biomarker
Time frame: [Time Frame: 5 days]
Change in concentration of trans-3'-hydroxycotinine in urine
Change in Biomarker
Time frame: [Time Frame: 5 days]
Change in concentration of Glucuronides in urine
Change in Biomarker
Time frame: [Time Frame: 5 days]
Change in concentration of Nicotine in blood
Change in Biomarker
Time frame: [Time Frame: 5 days]
Change in concentration of Cotinine in blood
Change in Biomarker
Time frame: [Time Frame: 5 days]
Change in concentration of trans-3'-hydroxycotinine in blood
Change in Biomarker
Time frame: [Time Frame: 5 days
Change in maximum concentration (Cmax) Plasma pharmacokinetic (PK) of Nicotine
Nicotine absorption
Time frame: [Time Frame: Day 7,
Change in time to maximum concentration (Tmax) Plasma PK of Nicotine
Nicotine absorption
Time frame: [Time Frame: Day 7,
Change of area under the curve (AUC) Plasma PK of Nicotine
Nicotine absorption
Time frame: [Time Frame: Day 7,
Product use over 5-day period and during 5-minute fixed and ad libitum use episodes
Change in product use
Time frame: [Time Frame: 7 days]
Measure of subjective Smoking Urge Assessment
Change in Assessment
Time frame: [Time Frame: 6-7 days, intervention dependent]
Measure of subjective product evaluation using the "modified Product Evaluation Scale (mPES)"
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.
Time frame: [Time Frame: 6-7 days, intervention dependent]
Measure of future intent to use JUUL 5% Device device relative to usual combustible cigarette and smoking cessation.
Change in Intent
Time frame: [Time Frame: 6-7 days, intervention dependent]
Number of participants with Adverse Events associated with use of JUUL 5% Device to combustible cigarette and smoking cessation
Safety
Time frame: [Time Frame: 13-14 days, intervention dependent]
Incidence of JUUL 5% Device, including malfunction and/or misuse
Device performance
Time frame: [Time Frame: 7 days]
Plan to share: No
Ran from Mar 2018 to primary completion in Jul 2018, 4 months.
Of 266 interventional studies with no phase under Tobacco Use Disorder, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Juul Labs, Inc.