| Eligibility |
Inclusion Criteria:
1. Able to read, understand, and willing to sign an informed consent form (ICF) and
complete questionnaires written in English.
2. Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of
consent.
3. Positive urine cotinine test at Screening.
4. Non-cylindrical, cartridge-based, closed system, ENDS are the primary form (> 50% of
total use over the last month) of tobacco- or nicotine-containing product used within
30 days of Screening.
5. Must have purchased and used 2 or more cartridges per week over the last 30 days.
Brief periods of abstinence due to illness, quit attempt (prior to 30 days of
Screening), or clinical study participation (prior to 30 days of Screening) will be
allowed at the discretion of the Principal Investigator (PI).
6. Primary flavor preference (75% use per week, self-reported) must be either Tobacco,
Mint/Menthol, or a Fruit/Berry flavor and listed in the acceptable UB product guide.
7. Females must be willing to use a form of contraception acceptable to the PI from the
time of signing the ICF until the end of the study.
8. Must be willing to use a the assigned non-cylindrical, cartridge-based product and
only the assigned flavor as their exclusive source of ENDS use for the full duration
of the 3-week ambulatory period.
9. Must have a modern IOS/Android phone (as described in the study procedures manual)
that allows for both Bluetooth connectivity and internet connectivity and be willing
to keep both active for the length of the study.
10. Must be willing to install an application onto their personal smartphone and keep the
application active for the length of the study.
Exclusion Criteria:
1. Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal,
hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological
disease, or any other concurrent disease or medical condition that, in the opinion of
the PI, makes the study participant unsuitable to participate in this clinical study.
2. History or presence of diabetes.
3. Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg,
measured after being seated for five minutes, with exceptions at the PI's discretion.
4. Scheduled treatment for asthma currently or within the past consecutive 12 months
prior to the Screening-Enrollment Visit. As-needed treatment, such as inhalers, may be
included at the PI's discretion pending approval from the Medical Monitor.
5. Any history of cancer, except for primary cancers of skin such as localized basal
cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
6. Use of any medication or substance that aids in smoking cessation, including but not
limited to any nicotine replacement therapy (NRT, e.g., nicotine gum, lozenge, patch),
varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (=)
30 days prior to the signing of informed consent.
7. Participation in another clinical trial within (=) 30 days prior to signing the ICF.
The 30-day window for each subject will be derived from the date of the last study
event in the previous study to the time of signing the ICF in the current study.
8. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to
become pregnant during the course of the study.
9. Individuals = 35 years of age currently using systemic, estrogen-containing
contraception or hormone replacement therapy.
10. A positive urine drug screen without evidence of prescribed corresponding concomitant
medication(s) at Screening.
11. Postpones a decision to quit using tobacco- or nicotine-containing products in order
to participate in this study or a previous attempt within (=) 30 days prior to the
signing of the ICF.
12. Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol
breathalyzer result at Screening.
13. Determined by the PI to be inappropriate for this study.
|
