CSD201201: Study to Assess Elements of Abuse Liability for Electronic Nicotine Delivery System P12 (NCT05210699) | Clinical Trial Compass
CompletedNot Applicable
CSD201201: Study to Assess Elements of Abuse Liability for Electronic Nicotine Delivery System P12
United States36 participantsStarted 2022-03-21
Plain-language summary
This is a randomized, open-label, 6-way crossover, multi-site study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]), and nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the Electronic Nicotine Delivery Systems (ENDS) investigational products (IPs) in generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.
Who can participate
Age range21 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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 to 60 years of age, inclusive, at the time of consent.
✓. Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
✓. Positive urine cotinine test at Screening.
✓. Smokes only combustible, filtered, menthol cigarettes, 83 mm to 100 mm in length.
✓. Agrees to smoke same usual brand (UB) cigarette throughout the study period. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.
✓. Subjects must meet one (a or b) of the following tobacco use conditions:
✓. Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. 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).
Exclusion criteria
✕. 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 subject unsuitable to participate in this clinical study.
. History, presence of, or clinical laboratory test results indicating diabetes.
✕. Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.
✕. Weight of ≤ 110 pounds.
✕. Hemoglobin level is \< 12.5 for females or \<13.0 for males g/dL at Screening.
✕. Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion pending approval from the Medical Monitor.
✕. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
✕. 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.