Study in adult smokers to evaluate changes in biomarkers of tobacco exposure after switching to exclusive use of the JUUL2 system
- Conditions
- Tobacco exposureNot Applicable
- Registration Number
- ISRCTN27662176
- Lead Sponsor
- Juul (United States)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 96
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
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 <18 kg/m² at Screening
8. Has a history of drug or alcohol abuse within 24 months of Check-in
9. Has diabetes mellitus, asthma, or chronic obstructive pulmonary disease
10. 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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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<br> 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<br> 3. Monohydroxybutenylmercapturic acid (MHBMA) evaluated through 24-hour urine collections on Day -1 to Day 1 and from Day 6 to Day 7<br> 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<br> 5. Blood carboxyhemoglobin (COHb) evaluated through blood samples taken on Day -1 and Day 6<br>
- Secondary Outcome Measures
Name Time Method