Modern Nicotine Oral Product Abuse Liability
An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Six Modern Nicotine Oral Products
1 other identifier
interventional
40
1 country
2
Brief Summary
This is a two-site, open-label, randomized, 8-way cross-over 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 the study investigational products (IPs) by generally healthy smokers.
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 Feb 2025
Shorter than P25 for not_applicable
2 active sites
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
January 10, 2025
CompletedFirst Posted
Study publicly available on registry
January 16, 2025
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2025
CompletedDecember 23, 2025
December 1, 2025
1 month
January 10, 2025
December 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
AUECPL 5-240
area under the effect curve (AUEC) for PL (VAS score-versus-time)
5 minutes to 240 minutes
Emax PL
maximum effect (maximum PL VAS score after the start of IP use)
240 minutes
Study Arms (8)
Product usage order ANBGCFDE
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order BACNDGEF
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order CBDAENFG
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order DCEBFAGN
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order EDFCGBNA
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order FEGDNCAB
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order GFNEADBC
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Product usage order NGAFBECD
EXPERIMENTALSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Interventions
Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette
Modern Nicotine Oral Product Cool Mint 6 mg Nicotine
Modern Nicotine Oral Product Cool Mint 12 mg Nicotine
Modern Nicotine Oral Product Cool Mint 15 mg Nicotine
Modern Nicotine Oral Product Smooth 6 mg Nicotine
Modern Nicotine Oral Product Wintergreen 6 mg Nicotine
Modern Nicotine Oral Product Dragon Fruit 6 mg Nicotine
Nicorette® White Ice Mint 4 mg nicotine gum
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.
- 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 (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the an investigator.
- Smokers who also use ST products (e.g., moist snuff, snus, modern oral), and have used ST within 30 days prior to screening, will be enrolled.
- 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 subject.
- Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and at check-in (Day -1).
- Positive urine cotinine test (e.g., \>200 ng/mL) via dipstick at Screening.
- 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).
- Willing to use the UB cigarette, Velo PLUS IPs, and Nicorette® nicotine gum during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each of eight 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: a) Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy); b) physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide; c) non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena); d) vasectomized partner; or e) post-menopausal and not on hormone replacement therapy.
- Agrees to an in-clinic confinement of ten days (nine nights).
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 last 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 subject 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.
- Weight of ≤ 110 pounds at screening or at check-in.
- 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®), or lobelia extract within (≤) 30 days prior to signing the informed consent.
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
AMR Lexington
Lexington, Kentucky, 40509, United States
AMR Knoxville
Knoxville, Tennessee, 37920, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian Keyser, PhD
Reynolds American
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
January 10, 2025
First Posted
January 16, 2025
Study Start
February 3, 2025
Primary Completion
March 5, 2025
Study Completion
March 5, 2025
Last Updated
December 23, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share