A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems
A Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
This will be an open-label, randomized, single-site, 8-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters and overall product liking (OPL) following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy adult combustible cigarette smokers and smokers who also use ENDS products.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2025
CompletedFirst Posted
Study publicly available on registry
January 7, 2026
CompletedStudy Start
First participant enrolled
March 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
January 7, 2026
December 1, 2025
2 months
December 22, 2025
December 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
AUC nic 0-240
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use
0 to 240 minutes
Cmax
Maximum baseline-adjusted plasma concentration of nicotine
240 minutes
Study Arms (8)
Product usage order AHBGCFDE
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order BACHDGEF
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order CBDAEHFG
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order DCEBFAGH
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order EDFCGBHA
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order FEGDHCAB
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order GFHEADBC
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order HGAFBECD
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Interventions
Tobacco Flavor, 5%
Fruit Flavor, 5%
Fruit Flavor, 5%
Fruit Flavor, 5%
Fruit Flavor, 5%
Menthol Flavor, 5%
Mint Flavor, 5%
Fruit Flavor, 5%
Eligibility Criteria
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 to 60 years of age, inclusive, at the time of consent.
- Expired breath carbon monoxide (ECO) 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.
- Participants 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 (more than 30 days prior to Screening), or clinical study participation (more than 30 days prior to Screening) will be allowed at the discretion of the Principal Investigator (PI).
- Dual user of cigarettes and ENDS who self-reports:
- i. Smoking at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt, or clinical study participation will be allowed at the discretion of the PI and ii. Using a nicotine-containing ENDS (cartridge or tank system). NOTE: Cigarette smokers or ENDS users who also use other tobacco- or nicotine-containing products (e.g., smokeless tobacco and modern oral nicotine products) on no more than 1 day per week will not be excluded from study participation.
- 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."
- Willing to use only UB cigarette and assigned test ENDS IPs during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each test session.
- Females must be willing to use a form of contraception acceptable to an Investigator, including abstinence from heterosexual intercourse, from the time of signing informed consent until EOS. Examples of acceptable means of birth control include, but are not limited to:
- Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy);
- +7 more criteria
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, 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 5 minutes at Screening and at Check-in Day 1.
- Weight of ≤ 110 pounds (≤ 50.0 kg) and body mass index of \> 40.0 kg/m2 at Screening.
- 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.
- 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.
- Must not be a current regular user (i.e., \> 5 times per month) of any tobacco- or nicotinecontaining products other than cigarettes or ENDS within the last 6 months prior to Screening.
- Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), glucagon-like peptide-1 (GLP-1) agonists (e.g., Wegovy®, Mounjaro®, Ozempic®), or lobelia extract within ≤ 30 days prior to the signing of informed consent.
- History or presence of bleeding or clotting disorders.
- Use of daily aspirin (≥ 325 mg) or other daily anticoagulants.
- Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and Check-in Day 1.
- NOTE: Participants will be advised against scheduling a whole blood donation for at least 7 days following study completion.
- Plasma donation within ≤ 7 days prior to the signing of informed consent and between Screening and Check-in Day 1.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Milly Kanobe
Reynolds American
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2025
First Posted
January 7, 2026
Study Start
March 15, 2026
Primary Completion (Estimated)
May 15, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
January 7, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share