Abuse Liability of Two Modern Oral Nicotine Pouched Products

NCT07595055 | Not Yet Recruiting

• 1 other identifier: IHI263001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-site, open-label, randomized, 4-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 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.

Conditions

Smoking; Smoking Behaviors; Tobacco Use; Tobacco Smoking

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 (4)

Product usage order ASBC

EXPERIMENTAL

Subjects will use each of the 4 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session

Other: Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette; Other: Modern Oral Pouch Wintergreen-A 9 mg Nicotine; Other: Modern Oral Pouch Wintergreen-B 9 mg Nicotine; Other: UB loose or pouched moist snuff

Product usage order BACS

EXPERIMENTAL

Subjects will use each of the 4 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session

Other: Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette; Other: Modern Oral Pouch Wintergreen-A 9 mg Nicotine; Other: Modern Oral Pouch Wintergreen-B 9 mg Nicotine; Other: UB loose or pouched moist snuff

Product usage order CBSA

EXPERIMENTAL

Subjects will use each of the 4 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session

Other: Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette; Other: Modern Oral Pouch Wintergreen-A 9 mg Nicotine; Other: Modern Oral Pouch Wintergreen-B 9 mg Nicotine; Other: UB loose or pouched moist snuff

Product usage order SCAB

EXPERIMENTAL

Subjects will use each of the 4 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session

Other: Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette; Other: Modern Oral Pouch Wintergreen-A 9 mg Nicotine; Other: Modern Oral Pouch Wintergreen-B 9 mg Nicotine; Other: UB loose or pouched moist snuff

Interventions

Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette OTHER

Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette

Product usage order ASBC; Product usage order BACS; Product usage order CBSA; Product usage order SCAB

Modern Oral Pouch Wintergreen-A 9 mg Nicotine OTHER

-A 9 mg Nicotine

Product usage order ASBC; Product usage order BACS; Product usage order CBSA; Product usage order SCAB

Modern Oral Pouch Wintergreen-B 9 mg Nicotine OTHER

-B 9 mg Nicotine

Product usage order ASBC; Product usage order BACS; Product usage order CBSA; Product usage order SCAB

UB loose or pouched moist snuff OTHER

UB loose or pouched moist snuff

Product usage order ASBC; Product usage order BACS; Product usage order CBSA; Product usage order SCAB

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 ST (e.g., moist snuff).
• 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 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 ST products (i.e., moist snuff) and agrees to use the same UB ST 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).
• Positive urine cotinine test (i.e., ≥200 ng/mL) via dipstick 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).
• Willing to use Study IPs, their UB cigarette and UB moist snuff (Study IP 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 four 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;

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 or tobacco heating device 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.
• 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.

Sponsors & Collaborators

• RAI Services Company: lead

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Interventions

Menthol; Nicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Brian Keyser

  Reynolds American

  STUDY DIRECTOR

Central Study Contacts

John Darnell

CONTACT

3367410386; darnelj2@rjrt.com

Kristen Prevette

CONTACT

3367411873; prevetk1@rjrt.com

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: May 6, 2026
• First Posted: May 19, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share