Tobacco exposure Not Applicable
Conditions
Interventions
Randomisation:
Each subject will be assigned a unique identification number upon screening. Subjects who complete the study screening assessments and meet all the eligibility (inclusion/exclusion) cri
Sponsors
Juul (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or female daily smoker, 21 to 65 years of age, inclusive, at Screening 2. 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 Investigator 3. Currently smokes an average of 10 or more conventional manufactured combustible cigarettes per day, as reported at Screening
Exclusion criteria
Exclusion criteria: 1. Has a history of everyday or some day use of vapour products or use of any vapour products within 2 weeks of Screening 2. Has a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, haematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results 3. Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, electrocardiogram (ECG), or clinical laboratory results, in the opinion of the Investigator 4. Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) 5. Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 14 days prior to Check-in 6. Has a fever (>38°C) at Screening or Check-in 7. Has a body mass index (BMI) >40 kg/m² or 150 mmHg, diastolic blood pressure 95 mmHg, or heart rate 99 bpm 11. Has experienced an allergic reaction following previous e-cigarette use or with exposure to benzoic acid, propylene glycol and glycerol 12. Has an estimated creatinine clearance <80 ml/minute (using the Cockcroft-Gault equation) at Screening 13. Has a positive urine screen for drugs of abuse or positive breath screen for alcohol at Screening or Day -2 (Check-in) 14. If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study 15. Has used medications known to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, clozapine, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, ropinirole, secobarbital, selegiline, sulconazole, theophylline, tioconazole, tranylcypromine) within 14 days or 5 half-lives of the drug, whichever is longer, prior to Check-in. 16. Has used nicotine-containing products other than manufactured cigarettes or ENDS (e.g., roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 30 days prior to Check-in, except as required per protocol (e.g., the brief product trial at Screening Visit 2) 17. Has used any prescription smoking abstinence treatments, including, but not limited to, varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Check-in 18. Is a self-reported puffer (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale) 19. Is planning to quit smoking during the study, planning to quit within 3 months following Day 1, or postponing a quit attempt in order to participate in the study 20. Is unwilling to abstain from all nicotine use for approximately 6.5 days, if assigned to the tobacco/nicotine abstinence group 21. Has a negative response (i.e., unwilling to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total urine 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) evaluated through 24-hour urine collections on Day -1 to Day 1 and from Day 6 to Day 7 2. 3-hydroxypropylmercapturic acid (3-HPMA) evaluated through 24-hour urine collections on Day -1 to Day 1 and from Day 6 to Day 7 3. Monohydroxybutenylmercapturic acid (MHBMA) evaluated through 24-hour urine collections on Day -1 to Day 1 and from Day 6 to Day 7 4. S-phenyl mercapturic acid (S-PMA) evaluated through 24-hour urine collections on Day -1 to Day 1 and from Day 6 to Day 7 5. Blood carboxyhemoglobin (COHb) evaluated through blood samples taken on Day -1 and Day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. How the product tested "made you feel" on a scale of 1 to7 measured using the Modified Product Evaluation Scale (mPES) from baseline to Day 6 2. How much "you like the product" on a scale of "not at all" to "a great deal" measured using the Product-Liking Questionnaire from baseline to Day 6 3. Urge to smoke measured on a scale of "not at all" to "extreme" measured using the Urge to Smoke a Cigarette Questionnaire from baseline to Day 6 4. Likeliness to use the product in the future on the scale of "definitely would not" to "definitely would" measured using the Future Intent to Use the Product Questionnaire from baseline to Day 6 5. For subjects randomised to JUUL2 System groups, puffing topography assessed via device Bluetooth connection and mobile application over the 6-day use period 6. Exhaled carbon monoxide measured using breath samples on Day -1 and Day 6 7. N-nitrosonornicotine (NNN) evaluated through 24-hour urine collections on Day-1 to Day 1 and from Day 6 to Day 7 8. 3-hydroxy-1-methylpropylmercapturic acid (HMPMA) evaluated through 24-hour urine collections on Day-1 to Day 1 and from Day 6 to Day 7 9. 2-cyanoethyl-mercapturic acid (CEMA) evaluated through 24-hour urine collections on Day-1 to Day 1 and from Day 6 to Day 7 10. Total 1-hydroxypyrene (1-OHP) evaluated through 24-hour urine collections on Day-1 to Day 1 and from Day 6 to Day 7 11. O-toluidine evaluated through 24-hour urine collections on Day-1 to Day 1 and from Day 6 to Day 7 12. 2-aminonaphthalen (2-NA) evaluated through 24-hour urine collections on Day-1 to Day 1 and from Day 6 to Day 7 13. 4-aminobiphenyl (4-ABP) evaluated through 24-hour urine collections on Day-1 to Day 1 and from Day 6 to Day 7 14. Nicotine equivalents evaluated through 24-hour urine collections on Day-1 to Day 1 and from Day 6 to Day 7 15. Product use data gathered by number of cigarettes used and pod weight change (JUUL2 Products) on Day -1 to Day 6 | — |
Countries
England, Poland, United Kingdom, Wales
Contacts
Public ContactSandra Miller
Outcome results
None listed