Abuse Liability of Four Modern Oral Nicotine Products
An In-Clinic Confinement Study to Assess Elements of Abuse Liability of Four Modern Oral Nicotine Products
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
This is a single-site, open-label, randomized, 6-way crossover study designed to evaluate elements of abuse liability (AL) including subjective effects, physiological measures (pharmacodynamics \[PD\]), and plasma nicotine uptake (pharmacokinetics \[PK\]) during controlled monitored use and following ad libitum use of the study investigational products (IPs) by generally healthy smokers who are also users of smokeless tobacco.
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 Jul 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
June 29, 2026
CompletedFirst Posted
Study publicly available on registry
July 6, 2026
CompletedStudy Start
First participant enrolled
July 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
July 6, 2026
June 1, 2026
2 months
June 29, 2026
June 29, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
AUECPL 5-60
area under the effect curve (AUEC) for PL (VAS score-versus-time)
5 minutes to 60 minutes
Emax PL
maximum effect (maximum PL VAS score after the start of IP use)
60 minutes
Study Arms (6)
Product usage order ASDECB
EXPERIMENTALSubjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
Product usage order BAESDC
EXPERIMENTALSubjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
Product usage order CBSAED
EXPERIMENTALSubjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
Product usage order DCABSE
EXPERIMENTALSubjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
Product usage order EDBCAS
EXPERIMENTALSubjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
Product usage order SECDBA
EXPERIMENTALSubjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
Interventions
Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette
Wintergreen (fleece A), 12 mg nicotine
Wintergreen (fleece A), 9 mg nicotine
Wintergreen (fleece B), 9 mg Nicotine
Watermelon Mint (fleece A), 9 mg Nicotine
UB moist snuff (UB MST), either loose or portioned (pouched).
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 males or females, 21 to 60 years of age, inclusive, at the time of consent.
- Smokes combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco and who also use MST. Participant's usual brand MST product needs to be a moist snuff tobacco product and not a Snus oral tobacco product.
- Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (occurring 30 days prior to Screening), or clinical study participation (occurring 30 days prior to Screening) will be allowed at the discretion of an investigator.
- Agrees to smoke the same UB cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand and style currently smoked most frequently by the participant.
- Reports daily use of MST products and agrees to use the same UB MST throughout the study period. The UB moist snuff is defined as the reported moist snuff brand and style currently used most frequently by the participant.
- Expired breath carbon monoxide (eCO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and at check-in (Day 1).
- 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" (Heatherton et al., 1991) OR response at Screening to "How soon after you wake up do you place your first dip?" is either "Within 5 minutes" or "6-30 minutes" from the Fagerström Test for Nicotine Dependance-Smokeless Tobacco (FTND-ST) (Ebbert et al., 2006).
- Positive urine cotinine test (i.e., ≥200 ng/mL) at Screening and at Check-in Day 1.
- Willing to use Study IPs, their UB cigarette and UB moist snuff (Product S) during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each of six Test Sessions.
- Females must be willing to use a form of contraception acceptable to an investigator from the time of signing the ICF until End-of-Study.
- Examples of acceptable means of birth control are, but 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;
- +6 more criteria
You may not qualify if:
- Allergic to or cannot tolerate mint or wintergreen flavoring agents.
- Individuals or their family members that have ongoing litigation with tobacco company(ies).
- Have used electronic nicotine delivery system (e.g., Vuse Alto, JUUL) or tobacco heating device (e.g., iQOS) within the 30 days prior to screening.
- 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.
- 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 discretion.
- History or presence of bleeding or clotting disorders.
- 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.
- Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for five minutes at Screening or at check-in Day 1.
- Hemoglobin level is \< 12.5 g/dL for females or \< 13.0 g/dL for males at Screening.
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).
- 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 signing the informed consent form.
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous quit attempt within (≤) 30 days prior to signing the informed consent.
- Any use of daily aspirin (≥ 325 mg) or any use of other anticoagulants.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian Keyser
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
June 29, 2026
First Posted
July 6, 2026
Study Start
July 15, 2026
Primary Completion (Estimated)
September 15, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
July 6, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share