Back to resultsUnited States Pre-Market Tobacco Application Pharmacokinetics (US-PMTA-PK)
Primary Purpose
Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Nicorette White Ice Mint 4mg nicotine polacrilex gum
Usual Brand combustible cigarette
Sponsored by
About this trial
This is an interventional other trial for Nicotine Dependence focused on measuring Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Vince & Associates Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
JUUL 5% Virginia Tobacco ENDS
JUUL 5% Cool Mint ENDS
JUUL 5% Mango ENDS
JUUL 5% Creme Brulee ENDS
VUSE Solo e-cigarette
Nicotine Gum
Usual Brand Combustible Cigarette
Arm Description
Treatment with JUUL Virginia Tobacco flavored 5.0% ENDS product.
Treatment with JUUL Cool Mint flavored 5.0% ENDS product.
Treatment with JUUL Mango flavored 5.0% ENDS product.
Treatment with JUUL Creme Brulee flavored 5.0% ENDS product.
Treatment with VUSE Solo Original with 4.8% nicotine product.
Treatment with nicorette white ice mint 4mg nicotine polacrilex gum product.
Treatment with usual brand combustible cigarette.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
To assess blood pressure following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum.
To assess heart rate following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum.
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.
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.
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
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)
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03719391
Brief Title
United States Pre-Market Tobacco Application Pharmacokinetics
Acronym
US-PMTA-PK
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Juul Labs, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
Keywords
Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, Open-Label, Cross-Over
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JUUL 5% Virginia Tobacco ENDS
Arm Type
Experimental
Arm Description
Treatment with JUUL Virginia Tobacco flavored 5.0% ENDS product.
Arm Title
JUUL 5% Cool Mint ENDS
Arm Type
Experimental
Arm Description
Treatment with JUUL Cool Mint flavored 5.0% ENDS product.
Arm Title
JUUL 5% Mango ENDS
Arm Type
Experimental
Arm Description
Treatment with JUUL Mango flavored 5.0% ENDS product.
Arm Title
JUUL 5% Creme Brulee ENDS
Arm Type
Experimental
Arm Description
Treatment with JUUL Creme Brulee flavored 5.0% ENDS product.
Arm Title
VUSE Solo e-cigarette
Arm Type
Active Comparator
Arm Description
Treatment with VUSE Solo Original with 4.8% nicotine product.
Arm Title
Nicotine Gum
Arm Type
Active Comparator
Arm Description
Treatment with nicorette white ice mint 4mg nicotine polacrilex gum product.
Arm Title
Usual Brand Combustible Cigarette
Arm Type
Active Comparator
Arm Description
Treatment with usual brand combustible cigarette.
Intervention Type
Other
Intervention Name(s)
Virginia Tobacco flavored JUUL 5% ENDS
Other Intervention Name(s)
JUUL
Intervention Description
Treatment with Virginia Tobacco flavored JUUL 5% ENDS (10 puffs).
Intervention Type
Other
Intervention Name(s)
Cool Mint flavored JUUL 5% ENDS
Other Intervention Name(s)
JUUL
Intervention Description
Treatment with Cool Mint flavored JUUL 5% ENDS (10 puffs).
Intervention Type
Other
Intervention Name(s)
Mango flavored JUUL 5% ENDS
Other Intervention Name(s)
JUUL
Intervention Description
Treatment with Mango flavored JUUL 5% ENDS (10 puffs).
Intervention Type
Other
Intervention Name(s)
Creme Brulee flavored JUUL 5% ENDS
Other Intervention Name(s)
JUUL
Intervention Description
Treatment with Creme Brulee flavored JUUL 5% ENDS (10 puffs).
Intervention Type
Other
Intervention Name(s)
VUSE Solo e-cigarette
Other Intervention Name(s)
VUSE
Intervention Description
Treatment with VUSE Solo Original with 4.8% nicotine e-cigarette (10 puffs).
Intervention Type
Other
Intervention Name(s)
Nicorette White Ice Mint 4mg nicotine polacrilex gum
Other Intervention Name(s)
Nicotine Gum
Intervention Description
Treatment with Nicorette White Ice Mint 4mg Nicotine polacrilex gum (30 minutes Chew and Park method)
Intervention Type
Other
Intervention Name(s)
Usual Brand combustible cigarette
Intervention Description
Treatment with usual brand cigarette (10 puffs).
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
7 Days
Title
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)"
Description
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
7 Days
Title
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
Title
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
Title
To assess the safety and tolerability of short-term use of four JUUL 5% ENDS.
Description
Number of participants with Adverse Events associated with use of JUUL 5% Device will be described by individual listings and frequency tables.
Time Frame
7 Days
Title
To characterize product use of four JUUL 5% ENDS during controlled use sessions.
Description
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.
Time Frame
7 Days
Title
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.
Description
The Intent to Use Again questionnaire will be assessed using a 100 mm bipolar VAS
Time Frame
7 Days
Title
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.
Description
The nicotine withdrawal will be assessed using a 100mm visual analog scale (VAS)
Time Frame
7 Days
Title
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.
Description
Product direct effect will be assessed using a 100 mm VAS
Time Frame
7 Days
Title
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.
Description
Product liking will be assessed using a 100 mm VAS
Time Frame
7 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
Vince & Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25607446
Citation
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Hatsukami 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.
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United States Pre-Market Tobacco Application Pharmacokinetics
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