A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products (NCT07739797) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products
50 participantsStarted 2026-10-01
Plain-language summary
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.
Who can participate
Age range
21 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 combustible filtered, menthol or non-menthol cigarettes, 83 mm to 100 mm in length.
. Agrees to smoke same UB cigarette throughout the study period. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the participant.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Participants must meet one (a or b) of the following tobacco use conditions:
. Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes."
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 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.
. Hemoglobin level is \< 12.5 g/dL for females or \<13.0 g/dL for males 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 an investigator's discretion.
. 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.