A clinical study to evaluate the contents of exhaled breath after use of the JUUL2 electronic nicotine delivery system and conventional cigarettes
- Conditions
- icotine exposureNot Applicable
- Registration Number
- ISRCTN16176441
- Lead Sponsor
- JUUL Labs Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 20
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
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 <90 mmHg or >150 mmHg, DBP <40 mmHg or >95 mmHg, or HR <40 beats per minute (bpm) or >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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method