Actively Recruiting
An In-Clinic Confinement Study to Assess Abuse Liability of Five Modern Oral Nicotine Products
Led by RAI Services Company · Updated on 2025-12-30
40
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the abuse potential of five modern oral nicotine products compared to combustible cigarettes and nicotine gum in generally healthy adult smokers aged 21 to 60 years. This open-label, randomized, cross-over study aims to assess subjective effects, physiological responses, and nicotine levels in the blood during and after use of these products. The study includes smokers who primarily use filtered menthol or non-menthol cigarettes, including those who also use smokeless tobacco or modern oral products. Participants will be randomly assigned to one of two study arms and use four different investigational products in separate test sessions following a Williams Design. The products include various nicotine doses delivered orally and participants' usual brand cigarettes or nicotine gum, depending on their arm. Each test session lasts about 4 hours and is preceded by a product acclimation period allowing ad libitum use of the next study product. Used products are collected and stored for laboratory analysis. Participants will stay confined at the clinical site for 6 days (5 nights) during which safety and effects will be closely monitored through vital signs, physical and oral exams, adverse event tracking, laboratory tests, and questionnaires. The main outcomes measured include nicotine uptake and peak response from 5 to 240 minutes after product use. The study also includes screening, eligibility confirmation, and follow-up availability by the medical monitor, with careful monitoring throughout the trial period.
CONDITIONS
Brief Title
Abuse Liability for Five Modern Oral Nicotine Products
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and willing to sign informed consent and complete questionnaires in English
- Generally healthy males or females aged 21 to 60 years
- Smokes filtered menthol or non-menthol combustible cigarettes as primary tobacco source
- Smokes at least 10 cigarettes per day and inhales smoke for at least 6 months prior to screening
- Smokers who also use smokeless tobacco products within 30 days prior to screening are eligible
- Willing to smoke the same usual brand cigarette throughout the study
- Expired breath carbon monoxide level between 10 and 100 ppm at screening
- Positive urine cotinine test above 200 ng/mL at screening
- Fagerström Test for Nicotine Dependence question 1 response within 30 minutes of waking
- Willing to use usual brand cigarette, study products, and nicotine gum (Arm 2 only) during the study
- Willing to abstain from tobacco and nicotine for at least 12 hours before each test session
- Females must agree to use acceptable contraception from consent until end of study
- Agree to stay confined in clinic for five days (four nights)
You will not qualify if you...
- Allergic or intolerant to mint or wintergreen flavoring
- Ongoing tobacco-related litigation involving participant or family
- Use of electronic nicotine delivery or tobacco heating devices within 30 days prior to screening
- Clinically significant uncontrolled diseases including cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological conditions
- History or presence of diabetes
- Current or recent treatment for asthma within past 12 months
- Bleeding or clotting disorders
- History of cancer except certain treated skin cancers
- Systolic blood pressure over 160 mmHg or diastolic over 95 mmHg at screening or check-in
- Weight less than or equal to 50 kg at screening or check-in
- Low hemoglobin levels at screening
- Pregnancy, breastfeeding, or positive pregnancy test
- Positive drug or alcohol tests at screening or check-in (except THC with evaluation)
- Positive HIV, hepatitis B, or hepatitis C tests
- Use of smoking cessation medications within 30 days prior to consent
- Planning to quit tobacco soon or recent quit attempts within 30 days
- Use of daily aspirin or other anticoagulants
- Age 35 or older using systemic hormone therapies
- Recent blood or plasma donation within specified timeframes
- Employment with tobacco or nicotine companies or handling raw tobacco products
- Participation in other clinical studies with investigational products recently
- Consuming more than 21 alcoholic drinks per week
- Investigator judgment deeming participant unsuitable for study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 45 days before check-in
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants check in at the clinical site to confirm eligibility, are enrolled, randomized, and confined for the study duration.
1 visit (in-person)
Duration - Half day before each test session
Participants use each study product ad libitum for acclimation prior to the next test session.
4 acclimation periods, each half a day
Duration - 4 days
Participants evaluate one assigned product per session with collection of subjective, physiological, and pharmacokinetic measures.
4 test sessions, each lasting approximately 4 hours
Duration - Throughout study confinement (6 days)
Safety assessments including adverse events, vital signs, physical and oral examinations, and laboratory tests are conducted throughout the study.
Daily monitoring visits
Trial Site Locations
Total: 1 location
1
Dr. Vince Clinical Research
Overland Park, Kansas, United States, 66212
Actively Recruiting
Research Team
J
John Darnell
K
Kristen Prevette
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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