Nicotine exposure Not Applicable
Conditions
Interventions
Randomisation:
Approximately 20 subjects will be screened for participation in the trial up to 28 days before Day 1. Along with screening procedures, all subjects will receive training on exhaled brea
the analysis lab will provide personnel to assist with sample collection. Pods used during the test sessions will be weighed before and after use.
Subjects will be assigned to one of the following 2 s
Sponsors
JUUL Labs Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in the study: 1. Is able to read and understand the ICF and provides voluntary consent to participate in this study documented on the signed ICF(s). 2. Adult, male or female smoker, 22 to 65 years of age, inclusive, at the Screening visit. 3. Has been a smoker =12 months prior to Screening. 4. Individuals who self-report smoking a minimum of 10 manufactured combustible menthol CPD for a minimum of 3 months prior to Screening. 5. Has past 30-day history of some day ENDS use. 6. Has a positive urine cotinine (=200 ng/mL) at the Screening visit and Day 1. 7. Has an eCO =10 ppm at the Screening visit. 8. Has an eCO <10 ppm at Day 1. 9. Completes the screening process within 28 days prior to study Day 1. 10. Is willing and able to comply with the requirements of the study, including a willingness to use the study products during the study and to stop smoking during the required abstention periods in the study. 11. A heterosexually active female subject of childbearing potential must have been using one of the following forms of contraception, and agree to continue using it through completion of the study: 11.1. hormonal (e.g., oral, vaginal ring, transdermal patch, implant, or injection) consistently for at least 3 months prior to study Day 1; 11.2. double-barrier method (e.g., condom with spermicide, diaphragm with spermicide) from Day 1; 11.3. intrauterine device for at least 3 months prior to study Day 1; 11.4. abstinence beginning at least 6 months prior to Day 1; 11.5. a partner who has been vasectomized for at least 6 months prior to Day 1. 12. A female subject of non-childbearing potential must be postmenopausal with amenorrhea for at least 1 year prior to study Day 1 or have undergone one of the following sterilization procedures at least 6 months prior to study Day 1: 12.1. hysteroscopic sterilization; 12.2. bilateral tubal ligation, occlusion, or bilateral salpingectomy; 12.3. hysterectomy; 12.4. bilateral oophorectomy
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria will not be enrolled in the study: 1. Has a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, laryngeal, oncologic, urologic, pulmonary (asthma, chronic obstructive pulmonary disease), immunologic, psychiatric, cardiovascular disease (hypertension, heart failure, chronic coronary syndrome, post-myocardial infarction status), diabetes mellitus, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. 2. At Screening, has a clinically significant abnormal finding on the physical examination, medical history, review of systems, medication list, or vital signs that, in the opinion of the Investigator (or medically qualified designee) might jeopardize participants safety or affect data validity. 3. Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 28 days prior to study Day 1. 4. Has a fever (>100.4°F [38oC]) at Screening visit. 5. Has a positive urine test result for drugs of abuse, or positive alcohol breath test at the Screening visit or at Day 1. If a positive urine drug test is observed, and it is believed that the positive urine test is due to prescription drugs, the PI should obtain documentation that: 5.1. confirms the subject’s use of the prescribed medication, and 5.2. the prescribed medication will cause a false positive drug test. 6. Has an SBP 150 mmHg, DBP 95 mmHg, or HR 99 bpm at Screening. 7. Has experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the e-liquids (nicotine, flavor, benzoic acid, propylene glycol and glycerol). 8. Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Screening. 9. If female, the subject is pregnant, has a positive pregnancy test at the Screening visit or at Day 1, is lactating, breast feeding, or intends to become pregnant during the time period from Screening through EOS. 10. Has used medications reported to interact with nicotine, including theophylline, ropinirole, and clozapine, within 14 days or 5 half-lives of the drug, whichever is longer, prior to study Day 1. 11. Has used any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or bupropion (Zyban®) within 30 days prior to study Day 1. 12. Requires concomitant treatment with prescription or non-prescription products that contain pseudoephedrine (e.g., nasal/sinus decongestants). 13. Negative response (i.e., unwilling to use or unable to tolerate [e.g., experiences AEs during the product familiarization that will prevent the subjects from continuing to use the JUUL product as judged by the PI]) to any of the JUUL products at the Screening visit. 14. Is a self-reported puffer (i.e., adult smokers who draw smoke from the cigarette and/or e-cigarette into the mouth and throat but do not inhale; will be observable during CPS training). 15. Is planning to quit smoking during the study or postponing a quit attempt in order to participate in the study. 16. Unable to perform CPS and draw down the JUUL2 pod weight by 20-60 mg after 3 attempts at the Screening visit. 17. Is or has a first-degree relative (i.e., parent, sibling, child)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute change from baseline (sham) level of specific constituents (nicotine, propylene glycol, vegetable glycerin, acetaldehyde, acrolein, formaldehyde, menthol, and CO) for each subject. All data will be summarized descriptively by study part and product. Continuous variables will be summarized using the mean, standard deviation, median, and range (minimum to maximum). For select variables, two-sided 90% CIs for the mean may also be provided to quantify the uncertainty associated with the estimated sample statistic. A linear mixed model will be used for the analysis of the primary endpoints. In the model, the response variable is the absolute change from baseline in the EBS level of a constituent and the fixed effect factor are the product group, sequence and period and the random effect is participant nested within sequence. For each EBS constituent, the least squared mean difference between UB cigarette (reference) and the JUUL2 product and 90% confidence interval will be provided. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
United States of America
Contacts
Public ContactSandra Miller
Outcome results
None listed