Nicotine DependenceUS-PMTA-PKNCT03719391
United States Pre-Market Tobacco Application Pharmacokinetics
A study testing Virginia Tobacco flavored JUUL 5% ENDS, Cool Mint flavored JUUL 5% ENDS and Mango flavored JUUL 5% ENDS in people with Nicotine Dependence and Nicotine Dependence, Cigarettes, run by Juul Labs, Inc. at 1 site in United States.
Trial summary
A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers 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, Nicotine Dependence, Cigarettes, Tobacco Use
- What is being tested?
- Virginia Tobacco flavored JUUL 5% ENDS, Cool Mint flavored JUUL 5% ENDS and Mango flavored JUUL 5% ENDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2018to 28 Nov 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, inclusive
- 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 that time will be permitted at the discretion of the PI.
- Currently smokes an average of 10 or more king size or 100s manufactured combustible CPD, as reported at Screening.
- Has a positive urine cotinine (≥ 500 ng/mL) at Screening
- Has an exhaled CO > 12 ppm at Screening.
- Is willing to comply with the requirements of the study, including a willingness to use the study products during the study.
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 PI, 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 PI.
- Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening.
- Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 14 days prior to Check-in.
- Has a fever (> 100.5°F) at Screening or Check-in.
- Has a body mass index (BMI) > 40.0 kg/m2 or < 18.0 kg/m2 at Screening.
Show all 24Show fewer
- Has a history of drug or alcohol abuse within 24 months of Check-in, as determined by the PI.
- Has diabetes mellitus, asthma, or chronic obstructive pulmonary disease.
- 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 experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the e-liquids (benzoic acid, propylene glycol and glycerol).
- Has an estimated creatinine clearance < 80 mL/minute (using the Cockcroft-Gault equation) at Screening.
- Has a positive urine screen for alcohol or drugs of abuse at Screening or Check-in.
- 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 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, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 14 days prior to Check-in.
- Has a prior history of JUUL product use 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 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 postponing a quit attempt in order to participate in the study.
- Has donated plasma within 7 days prior to Check-in.
- Has donated blood or blood products (with the exception of plasma as noted above), had significant blood loss, or received whole blood or a blood product transfusion within 56 days prior to Check-in.
- Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Check-in.
- Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee of the study site.
- 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 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince & Associates Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers
A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers
Read the detailed description
E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing vaporization rather than combustion, the generation and inhaltion of smoke and carbon monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid blends for use in e-cigarettes. This study will assess nicotine uptake during a 10-puff controlled and a 5-minute ad libitum use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum.
- Being tested
- Virginia Tobacco flavored JUUL 5% ENDS, Cool Mint flavored JUUL 5% ENDS, Mango flavored JUUL 5% ENDS, Creme Brulee flavored JUUL 5% ENDS, VUSE Solo e-cigarette
- Keywords
- Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use, Tobacco Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virginia Tobacco flavored JUUL 5% ENDSOther
Also called JUUL
Treatment with Virginia Tobacco flavored JUUL 5% ENDS (10 puffs).
Cool Mint flavored JUUL 5% ENDSOther
Also called JUUL
Treatment with Cool Mint flavored JUUL 5% ENDS (10 puffs).
Mango flavored JUUL 5% ENDSOther
Also called JUUL
Treatment with Mango flavored JUUL 5% ENDS (10 puffs).
Creme Brulee flavored JUUL 5% ENDSOther
Also called JUUL
Treatment with Creme Brulee flavored JUUL 5% ENDS (10 puffs).
VUSE Solo e-cigaretteOther
Also called VUSE
Treatment with VUSE Solo Original with 4.8% nicotine e-cigarette (10 puffs).
Nicorette White Ice Mint 4mg nicotine polacrilex gumOther
Also called Nicotine Gum
Treatment with Nicorette White Ice Mint 4mg Nicotine polacrilex gum (30 minutes Chew and Park method)
Usual Brand combustible cigaretteOther
Treatment with usual brand cigarette (10 puffs).
| Study group | Role | What they receive |
|---|---|---|
| JUUL 5% Virginia Tobacco ENDS | Experimental | Treatment with JUUL Virginia Tobacco flavored 5.0% ENDS product. Receives: Other: Virginia Tobacco flavored JUUL 5% ENDS |
| JUUL 5% Cool Mint ENDS | Experimental | Treatment with JUUL Cool Mint flavored 5.0% ENDS product. Receives: Other: Cool Mint flavored JUUL 5% ENDS |
| JUUL 5% Mango ENDS | Experimental | Treatment with JUUL Mango flavored 5.0% ENDS product. Receives: Other: Mango flavored JUUL 5% ENDS |
| JUUL 5% Creme Brulee ENDS | Experimental | Treatment with JUUL Creme Brulee flavored 5.0% ENDS product. Receives: Other: Creme Brulee flavored JUUL 5% ENDS |
| VUSE Solo e-cigarette | Active comparator | Treatment with VUSE Solo Original with 4.8% nicotine product. Receives: Other: VUSE Solo e-cigarette |
| Nicotine Gum | Active comparator | Treatment with nicorette white ice mint 4mg nicotine polacrilex gum product. Receives: Other: Nicorette White Ice Mint 4mg nicotine polacrilex gum |
| Usual Brand Combustible Cigarette | Active comparator | Treatment with usual brand combustible cigarette. Receives: Other: Usual Brand combustible cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess nicotine uptake during a 10-puff controlled use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum.
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP. Baseline adjustments to the (non-adjusted) PK endpoints will also be presented.
Measured: 7 days
Secondary outcomes (10)
To assess exhaled carbon monoxide [CO] following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum
Exhaled CO levels will be measured using a Bedfont Micro+ Smokerlyzer or similar device and levels at Screening and after product use will be assessed.
Measured: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum 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: 7 Days
To assess blood pressure following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum.
Measured: 7 Days
To assess heart rate following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum.
Measured: 7 Days
To assess the safety and tolerability of short-term use of four JUUL 5% ENDS.
Number of participants with Adverse Events associated with use of JUUL 5% Device will be described by individual listings and frequency tables.
Measured: 7 Days
To characterize product use of four JUUL 5% ENDS during controlled use sessions.
All product use data will be summarized using descriptive statistics. The difference in weight pre- and post- product use of each JUUL product and comparator e-cigarettes will be summarized.
Measured: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Intent to Use Again Questionnaire.
The Intent to Use Again questionnaire will be assessed using a 100 mm bipolar VAS
Measured: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Nicotine Withdrawal Questionnaire.
The nicotine withdrawal will be assessed using a 100mm visual analog scale (VAS)
Measured: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Product Direct Effect Questionnaire.
Product direct effect will be assessed using a 100 mm VAS
Measured: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Product Liking Questionnaire.
Product liking will be assessed using a 100 mm VAS
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start19 Oct 2018
- Primary completion21 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies 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
- Crossover
- Model description
- Randomized, Open-Label, Cross-Over
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juul Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719391
- Sponsor's protocol ID
- PROT-00009
- Acronym
- US-PMTA-PK
- Status last verified
- Jan 2019
- First submitted
- 17 Oct 2018
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 25607446D'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 27401980McNeill 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 24814944Fagerstrom 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 22025545Hatsukami DK, Zhang Y, O'Connor RJ, Severson HH. Subjective responses to oral tobacco products: scale validation. Nicotine Tob Res. 2013 Jul;15(7):1259-64. doi: 10.1093/ntr/nts265. Epub 2012 Dec 13.
PubMed 23239843HIPAA 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers
- ClinicalTrials.gov ID
- NCT03719391
- Acronym / sponsor ID
- US-PMTA-PK / PROT-00009
- Keywords
- Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Juul Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 25 Oct 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.
A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers
Detailed description
E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing vaporization rather than combustion, the generation and inhaltion of smoke and carbon monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid blends for use in e-cigarettes. This study will assess nicotine uptake during a 10-puff controlled and a 5-minute ad libitum use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Randomized, Open-Label, Cross-Over
| Arm | Type | Receives |
|---|---|---|
| JUUL 5% Virginia Tobacco ENDS | Experimental | Other: Virginia Tobacco flavored JUUL 5% ENDSTreatment with JUUL Virginia Tobacco flavored 5.0% ENDS product. |
| JUUL 5% Cool Mint ENDS | Experimental | Other: Cool Mint flavored JUUL 5% ENDSTreatment with JUUL Cool Mint flavored 5.0% ENDS product. |
| JUUL 5% Mango ENDS | Experimental | Other: Mango flavored JUUL 5% ENDSTreatment with JUUL Mango flavored 5.0% ENDS product. |
| JUUL 5% Creme Brulee ENDS | Experimental | Other: Creme Brulee flavored JUUL 5% ENDSTreatment with JUUL Creme Brulee flavored 5.0% ENDS product. |
| VUSE Solo e-cigarette | Active comparator | Other: VUSE Solo e-cigaretteTreatment with VUSE Solo Original with 4.8% nicotine product. |
| Nicotine Gum | Active comparator | Other: Nicorette White Ice Mint 4mg nicotine polacrilex gumTreatment with nicorette white ice mint 4mg nicotine polacrilex gum product. |
| Usual Brand Combustible Cigarette | Active comparator | Other: Usual Brand combustible cigaretteTreatment with usual brand combustible cigarette. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy, adult, male or female smoker, 21 to 65 years of age, inclusive
- 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 that time will be permitted at the discretion of the PI.
- Currently smokes an average of 10 or more king size or 100s manufactured combustible CPD, as reported at Screening.
- Has a positive urine cotinine (≥ 500 ng/mL) at Screening
- Has an exhaled CO > 12 ppm at Screening.
Key exclusion criteria (24 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 PI, 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 PI.
- Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening.
- Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 14 days prior to Check-in.
- Has a fever (> 100.5°F) at Screening or 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 |
|---|---|---|
| Virginia Tobacco flavored JUUL 5% ENDSAlso: JUULTreatment with Virginia Tobacco flavored JUUL 5% ENDS (10 puffs). | Other | JUUL 5% Virginia Tobacco ENDS |
| Cool Mint flavored JUUL 5% ENDSAlso: JUULTreatment with Cool Mint flavored JUUL 5% ENDS (10 puffs). | Other | JUUL 5% Cool Mint ENDS |
| Mango flavored JUUL 5% ENDSAlso: JUULTreatment with Mango flavored JUUL 5% ENDS (10 puffs). | Other | JUUL 5% Mango ENDS |
| Creme Brulee flavored JUUL 5% ENDSAlso: JUULTreatment with Creme Brulee flavored JUUL 5% ENDS (10 puffs). | Other | JUUL 5% Creme Brulee ENDS |
| VUSE Solo e-cigaretteAlso: VUSETreatment with VUSE Solo Original with 4.8% nicotine e-cigarette (10 puffs). | Other | VUSE Solo e-cigarette |
| Nicorette White Ice Mint 4mg nicotine polacrilex gumAlso: Nicotine GumTreatment with Nicorette White Ice Mint 4mg Nicotine polacrilex gum (30 minutes Chew and Park method) | Other | Nicotine Gum |
| Usual Brand combustible cigaretteTreatment with usual brand cigarette (10 puffs). | Other | Usual Brand Combustible Cigarette |
Primary outcome
To assess nicotine uptake during a 10-puff controlled use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum.
Time frame: 7 days
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP. Baseline adjustments to the (non-adjusted) PK endpoints will also be presented.
10 secondary outcomes
To assess exhaled carbon monoxide [CO] following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum
Time frame: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using the "modified Product Evaluation Scale (mPES)"
Time frame: 7 Days
To assess blood pressure following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum.
Time frame: 7 Days
To assess heart rate following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum.
Time frame: 7 Days
To assess the safety and tolerability of short-term use of four JUUL 5% ENDS.
Time frame: 7 Days
To characterize product use of four JUUL 5% ENDS during controlled use sessions.
Time frame: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Intent to Use Again Questionnaire.
Time frame: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Nicotine Withdrawal Questionnaire.
Time frame: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Product Direct Effect Questionnaire.
Time frame: 7 Days
To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using Product Liking Questionnaire.
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 14 Jun 2021.
- 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 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.
- Background: PubMed 23239843Hatsukami DK, Zhang Y, O'Connor RJ, Severson HH. Subjective responses to oral tobacco products: scale validation. Nicotine Tob Res. 2013 Jul;15(7):1259-64. doi: 10.1093/ntr/nts265. Epub 2012 Dec 13.
- 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.
- Individual participant dataSharing planned: No
Related trials for Nicotine Dependence
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virginia Tobacco flavored JUUL 5% ENDS, Cool Mint flavored JUUL 5% ENDS and Mango flavored JUUL 5% ENDS in people with Nicotine Dependence and Nicotine Dependence, Cigarettes, 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 6 inclusion and 24 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 14 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. 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?
To assess nicotine uptake during a 10-puff controlled use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum. (time frame: 7 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 NCT03719391, which also lists 7 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 14 Jun 2021.