A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorRAI Services Company
About this trial
This will be a randomized, open-label, 8-way crossover, single-site study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics \[PD\]), and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of electronic nicotine delivery system (ENDS) investigational products (IPs). The study will be conducted in a confinement setting among generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 an investigator, makes the study participant 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 (≤ 50.0 kg) at Screening.
Trial design
Treatments tested in this trial
- Golden Tobacco Chill 5% (4) 6.5W
- Glacier Menthol 5% (4) 6.5W
- Fresh Mint 5% (4) 6.5W
- Fresh Mint 5% (4) 4.5W
- Fresh Mint 5% (3) 6.5W
- Fresh Mint 5% (3) 5.5W
- Fresh Mint 5% (2) 6.5W
- Usual Brand Cigarette
Treatment groups
50 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov