Actively Recruiting
Abuse Liability for Five Modern Oral Nicotine Products
Led by RAI Services Company · Updated on 2025-12-30
40
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a two-site, open-label, randomized, 4-way (2 arm) 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
CONDITIONS
Official 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
- Currently smoke filtered, non-menthol or menthol combustible cigarettes 83 mm to 100 mm in length as primary tobacco source
- Smoke at least 10 cigarettes per day and inhale smoke for at least 6 months prior to screening
- Smokers who also use smokeless tobacco products and have used them within 30 days prior to screening
- Agree to smoke the same usual brand cigarette during the study
- Expired breath carbon monoxide level between 10 and 100 ppm at screening
- Positive urine cotinine test at screening
- Fagerström Test for Nicotine Dependence Question 1 response is "Within 5 minutes" or "6-30 minutes"
- Willing to use usual brand cigarette, study investigational products, and nicotine gum if in Arm 2
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each test session
- Females willing to use acceptable contraception from consent until end of study
- Agree to in-clinic confinement for five days (four nights)
You will not qualify if you...
- Allergic to or intolerant of mint or wintergreen flavoring agents
- Individual or family involved in ongoing litigation with tobacco companies
- Used electronic nicotine delivery systems or tobacco heating devices within 30 days prior to screening
- Clinically significant uncontrolled diseases or conditions making participation unsuitable
- History or clinical indication of diabetes
- Scheduled asthma treatment currently or within past 12 months, except as-needed inhalers at investigator discretion
- History or presence of bleeding or clotting disorders
- History of cancer except localized skin cancers treated surgically or cryogenically
- Blood pressure over 160/95 mmHg after resting at screening or check-in
- Weight 50.0 kg or less at screening or check-in
- Low hemoglobin levels at screening (<12.5 g/dL females, <13.0 g/dL males)
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Positive urine drug or alcohol test at screening or check-in, except THC with evaluation
- Positive test for HIV, hepatitis B surface antigen, or hepatitis C virus
- Use of smoking cessation aids within 30 days prior to consent
- Postponed quitting tobacco or recent quit attempt within 30 days prior to consent
- Use of daily aspirin over 325 mg or other anticoagulants
- Individuals aged 35 or older using systemic testosterone, estrogen contraception, or hormone therapy
- Recent blood or plasma donation exceeding limits prior to consent or between screening and check-in
- Employment with tobacco or nicotine companies or study site or handling raw tobacco products
- Use of investigational drugs or tobacco/nicotine products within 30 days or 5 half-lives prior to screening
- Drinking more than 21 alcoholic beverages per week
- Determined unsuitable for the study by an investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dr. Vince Clinical Research
Overland Park, Kansas, United States, 66212
Actively Recruiting
Research Team
J
John Darnell
CONTACT
K
Kristen Prevette
CONTACT
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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