CSD190501: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting

Completed · Not applicable

Conditions studied: Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking

In brief

This study will be a single-center, controlled, open-label, parallel study to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to an ENDS Investigational Product (IP) product with 4.8% nicotine over a three-week ambulatory period. This study will be conducted in support of a Premarket Tobacco Product Application (PMTA) ENDS submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).

Key facts

Study ID

NCT04226404

Run by

RAI Services Company

People needed

75

Starts

2020-01-14

Expected to finish

2020-02-27

Last updated by the study team

2020-09-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
• Generally healthy male or female, ≥21 years of age, inclusive, at the time of consent.
• Positive urine cotinine test at Screening.
• Cartridge-based, closed-system ENDS are the primary form of tobacco/nicotine-containing products used within 30 days of Screening. Subjects may be users of other tobacco/nicotine-containing products. If the subject is a dual/poly user of tobacco/nicotine-containing products then the subject must self report that a cartridge-based, closed-system ENDS is their primary product.
• Must have used 2 or more ENDS 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).
• 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.
• Must be willing to use the assigned IP and only the assigned flavor as their exclusive source of ENDS use for the full duration of the three-week ambulatory period. Use of other non-ENDS tobacco/nicotine-containing products will be permitted during the ambulatory period.
• Must have familiarity with modern electronic devices such as an IOS/Android smart phone or tablet computer ("tablet") and be willing to be provided an electronic device, that allows for both Bluetooth connectivity and internet connectivity and be willing to keep both active for the length of the study.
• Must be willing to use an application on the provided electronic device, and keep the application active for the length of the study.

You may not qualify if…

• 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.
• History or presence of diabetes.
• 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.
• 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.
• 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.
• 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.
• 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.
• Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
• Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
• A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening.
• Postpones a decision to quit using tobacco/nicotine-containing products in order to participate in this study or a previous attempt within (≤) 30 days prior to the signing of the ICF.
• Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol breathalyzer result at Screening.
• Determined by the PI to be inappropriate for this study.

Where it is running

• New Orleans Center for Clinical Research (NOCCR) — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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