Nicotine Dependence, Other Tobacco ProductDiamondNCT03463837
Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers
A study testing Treatment with JUUL 5%, Virginia Tobacco, Treatment with JUUL 5%, Cool Mint, ENDS and Treatment with JUUL 5%, Mango, ENDS in people with Nicotine Dependence, Other Tobacco Product and Tobacco Use, run by Juul Labs, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Other Tobacco Product, Tobacco Use, Smoking, Tobacco
- What is being tested?
- Treatment with JUUL 5%, Virginia Tobacco, Treatment with JUUL 5%, Cool Mint, ENDS and Treatment with JUUL 5%, Mango, ENDS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2018to 13 Aug 2018
- 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
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Treatment with JUUL 5%, Virginia Tobacco, Treatment with JUUL 5%, Cool Mint, ENDS, Treatment with JUUL 5%, Mango, ENDS, JUUL 5%, Creme Bruele, ENDS, Combustible cigarette
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with JUUL 5%, Virginia TobaccoOther
Also called JUUL
JUUL 5%, ENDS for 5-days in confinement
Treatment with JUUL 5%, Cool Mint, ENDSOther
Also called JUUL
JUUL 5%, ENDS for 5-days in confinement
Treatment with JUUL 5%, Mango, ENDSOther
Also called JUUL
JUUL 5%, ENDS for 5-days in confinement
JUUL 5%, Creme Bruele, ENDSOther
Also called JUUL
JUUL 5%, ENDS for 5-days in confinement
Combustible cigaretteOther
Exclusive use of combustible cigarette for 5 days in confinement.
Smoking CessationOther
No smoking for 5-days in confinement.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with JUUL 5%, Virginia Tobacco | Experimental | JUUL 5%,Virginia Tobacco [5 days] in confinement. Receives: Other: Treatment with JUUL 5%, Virginia Tobacco |
| Treatment with JUUL 5%, Cool Mint, ENDS | Experimental | JUUL 5%, Cool Mint [5 days] in confinement. Receives: Other: Treatment with JUUL 5%, Cool Mint, ENDS |
| Treatment with JUUL 5%, Mango, ENDS | Experimental | JUUL 5%, Mango [5 days] in confinement. Receives: Other: Treatment with JUUL 5%, Mango, ENDS |
| JUUL 5%, Creme Bruele, ENDS | Experimental | JUUL 5%, Creme Bruele [5 days] in confinement. Receives: Other: JUUL 5%, Creme Bruele, ENDS |
| Combustible cigarette | Active comparator | Exclusive use of combustible cigarette [5 days] in confinement. Receives: Other: Combustible cigarette |
| Smoking cessation (no smoking) | Sham comparator | Smoking cessation (no smoking). Receives: Other: Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: [Time Frame: 5 days]
Secondary outcomes (19)
Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine
Change in Biomarker
Measured: [Time Frame: 5 days]
Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) in urine
Change in Biomarker
Measured: [Time Frame: 5 days]
Change in concentration of 1-hydroxypyrene (1-OHP) in urine
Change in Biomarker
Measured: [Time Frame: 5 days]
Change in concentration of Nicotine in urine
Change in Biomarker
Measured: [Time Frame: 5 days]
Change in concentration of Cotinine in urine
Change in Biomarker
Measured: [Time Frame: 5 days]
Change in concentration of trans-3'-hydroxycotinine in urine
Change in Biomarker
Measured: [Time Frame: 5 days]
Change in concentration of Glucuronides in urine
Change in Biomarker
Measured: [Time Frame: 5 days]
Change in concentration of Nicotine in blood
Change in Biomarker
Measured: [Time Frame: 5 days]
Change in concentration of Cotinine in blood
Change in Biomarker
Measured: [Time Frame: 5 days]
Change in concentration of trans-3'-hydroxycotinine in blood
Change in Biomarker
Measured: [Time Frame: 5 days
Change in maximum concentration (Cmax) Plasma pharmacokinetic (PK) of Nicotine
Nicotine absorption
Measured: [Time Frame: Day 7,
Change in time to maximum concentration (Tmax) Plasma PK of Nicotine
Nicotine absorption
Measured: [Time Frame: Day 7,
Change of area under the curve (AUC) Plasma PK of Nicotine
Nicotine absorption
Measured: [Time Frame: Day 7,
Product use over 5-day period and during 5-minute fixed and ad libitum use episodes
Change in product use
Measured: [Time Frame: 7 days]
Measure of subjective Smoking Urge Assessment
Change in Assessment
Measured: [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.
Measured: [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
Measured: [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
Measured: [Time Frame: 13-14 days, intervention dependent]
Incidence of JUUL 5% Device, including malfunction and/or misuse
Device performance
Measured: [Time Frame: 7 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start4 Mar 2018
- Primary completion27 Jul 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nicotine Dependence, Other Tobacco ProductStudies 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juul Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Philip Mathew, M.D., Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463837
- Sponsor's protocol ID
- 755-00041
- Acronym
- Diamond
- Status last verified
- Jan 2019
- First submitted
- 7 Mar 2018
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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 27401980Jensen 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 25607446McNeill 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03463837
- Acronym / sponsor ID
- Diamond / 755-00041
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Juul Labs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 4 Mar 2018 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 13 Mar 2018 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment with JUUL 5%, Virginia Tobacco | Experimental | Other: Treatment with JUUL 5%, Virginia TobaccoJUUL 5%,Virginia Tobacco [5 days] in confinement. |
| Treatment with JUUL 5%, Cool Mint, ENDS | Experimental | Other: Treatment with JUUL 5%, Cool Mint, ENDSJUUL 5%, Cool Mint [5 days] in confinement. |
| Treatment with JUUL 5%, Mango, ENDS | Experimental | Other: Treatment with JUUL 5%, Mango, ENDSJUUL 5%, Mango [5 days] in confinement. |
| JUUL 5%, Creme Bruele, ENDS | Experimental | Other: JUUL 5%, Creme Bruele, ENDSJUUL 5%, Creme Bruele [5 days] in confinement. |
| Combustible cigarette | Active comparator | Other: Combustible cigaretteExclusive use of combustible cigarette [5 days] in confinement. |
| Smoking cessation (no smoking) | Sham comparator | Other: Smoking CessationSmoking cessation (no smoking). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Treatment with JUUL 5%, Virginia TobaccoAlso: JUULJUUL 5%, ENDS for 5-days in confinement | Other | Treatment with JUUL 5%, Virginia Tobacco |
| Treatment with JUUL 5%, Cool Mint, ENDSAlso: JUULJUUL 5%, ENDS for 5-days in confinement | Other | Treatment with JUUL 5%, Cool Mint, ENDS |
| Treatment with JUUL 5%, Mango, ENDSAlso: JUULJUUL 5%, ENDS for 5-days in confinement | Other | Treatment with JUUL 5%, Mango, ENDS |
| JUUL 5%, Creme Bruele, ENDSAlso: JUULJUUL 5%, ENDS for 5-days in confinement | Other | JUUL 5%, Creme Bruele, ENDS |
| Combustible cigaretteExclusive use of combustible cigarette for 5 days in confinement. | Other | Combustible cigarette |
| Smoking CessationNo smoking for 5-days in confinement. | Other | Smoking cessation (no smoking) |
Primary outcome
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)
19 secondary outcomes
Change in concentration of 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) in urine
Time frame: [Time Frame: 5 days]
Change in concentration of 2-cyanoethyl-mercapturic acid (CEMA) in urine
Time frame: [Time Frame: 5 days]
Change in concentration of 1-hydroxypyrene (1-OHP) in urine
Time frame: [Time Frame: 5 days]
Change in concentration of Nicotine in urine
Time frame: [Time Frame: 5 days]
Change in concentration of Cotinine in urine
Time frame: [Time Frame: 5 days]
Change in concentration of trans-3'-hydroxycotinine in urine
Time frame: [Time Frame: 5 days]
Change in concentration of Glucuronides in urine
Time frame: [Time Frame: 5 days]
Change in concentration of Nicotine in blood
Time frame: [Time Frame: 5 days]
Change in concentration of Cotinine in blood
Time frame: [Time Frame: 5 days]
Change in concentration of trans-3'-hydroxycotinine in blood
Time frame: [Time Frame: 5 days
Change in maximum concentration (Cmax) Plasma pharmacokinetic (PK) of Nicotine
Time frame: [Time Frame: Day 7,
Change in time to maximum concentration (Tmax) Plasma PK of Nicotine
Time frame: [Time Frame: Day 7,
Change of area under the curve (AUC) Plasma PK of Nicotine
Time frame: [Time Frame: Day 7,
Product use over 5-day period and during 5-minute fixed and ad libitum use episodes
Time frame: [Time Frame: 7 days]
Measure of subjective Smoking Urge Assessment
Time frame: [Time Frame: 6-7 days, intervention dependent]
Measure of subjective product evaluation using the "modified Product Evaluation Scale (mPES)"
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.
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
Time frame: [Time Frame: 13-14 days, intervention dependent]
Incidence of JUUL 5% Device, including malfunction and/or misuse
Time frame: [Time Frame: 7 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 21 Jun 2021.
- 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. Last accessed 31-Jul-2017.
- Results publication: 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.
- Results publication: 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.
- Results publicationMcNeill 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).
- Results publication: 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.
- 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.
Philip Mathew, M.D. principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with JUUL 5%, Virginia Tobacco, Treatment with JUUL 5%, Cool Mint, ENDS and Treatment with JUUL 5%, Mango, ENDS in people with Nicotine Dependence, Other Tobacco Product and Tobacco Use, run by Juul Labs, Inc. at 1 site in United States.
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 7 inclusion and 7 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 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Change in primary biomarkers day 5 values for each JUUL 5% product will be compared to baseline: (time frame: [Time Frame: 5 days]). 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 NCT03463837, which also lists 5 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 21 Jun 2021.