A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products
An Open-Label, Randomized, 8-way Crossover Study to Assess Elements of Abuse Liability Electronic Nicotine Delivery System Products in Adult Smokers
1 other identifier
interventional
50
0 countries
N/A
Brief 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.
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 Oct 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
July 28, 2026
CompletedFirst Posted
Study publicly available on registry
July 31, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
Study Completion
Last participant's last visit for all outcomes
April 1, 2027
July 31, 2026
July 1, 2026
2 months
July 28, 2026
July 28, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
AUC nic 3-240
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time 3 to 240 minutes after the start of IP use
3 minutes to 240 minutes
Emax PL
maximum PL VAS score after the start of IP use
240 minutes
Study Arms (8)
Product usage order BCNDHEGF
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
Product usage order CDBENFHG
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
Product usage order DECFBGNH
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
Product usage order EFDGCHBN
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
Product usage order FGEHDNCB
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
Product usage order GHFNEBDC
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
Product usage order HNGBFCED
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
Product usage order NBHCGDFE
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
Interventions
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
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 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:
- a. Sole smoker of filtered menthol or non-menthol cigarettes 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 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 an investigator b. 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 Visit. 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 an investigator, and ii. Using a nicotine-containing ENDS (cartridge or a 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 one 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 cigarettes and 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 from the time of signing informed consent until End-of-Study. Examples of acceptable means of birth control include, but are not limited to:
- Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy);
- Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide;
- Non-hormone releasing intrauterine devices (IUDs) or hormone-releasing IUDs (e.g., Mirena or Kyleena);
- +5 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 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.
- Must not be a current regular user (i.e., \> 5 times per month) of any tobacco 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®), GLP-1 agonists (e.g., Wegovy®, Mounjaro®, and 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
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
July 28, 2026
First Posted
July 31, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share