An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Five Modern Oral Nicotine Products
RAI Services Company
Summary
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
Description
Cigarette smokers of (only) filtered menthol and/or non-menthol cigarettes naïve to smokeless tobacco products (ST) and/or modern oral tobacco (MO) products and smokers also using ST and/or MO will be recruited into this AL study to evaluate elements of AL of five modern oral nicotine products (hereinafter, Study IPs) compared to combustible cigarettes (CC) only (Arm 1) and combustible and and nicotine polacrilex gum (Arm 2). An attempt will be made for at least one-third of the study population to include smokers using ST and/or MO for each arm. Potential participants will complete a pre-scr…
Eligibility
- Age range
- 21–60 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English. 2. Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent. 3. Smokes combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco. 4. 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 st…
Interventions
- OtherProduct A
Usual Brand (UB) filtered, non-menthol or menthol combustible cigarette
- OtherProduct B
8 mg nicotine oral product
- OtherProduct C
12 mg nicotine oral product
- OtherProduct D
6 mg nicotine oral product
- OtherProduct E
8 mg nicotine oral product
- OtherProduct F
8 mg nicotine oral product
- OtherProduct N
Nicorette® White Ice Mint 4 mg nicotine polacrilex gum
Location
- Dr. Vince Clinical ResearchOverland Park, Kansas