NCT07132814 Abuse Liability for Five Modern Oral Nicotine Products
| NCT ID | NCT07132814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RAI Services Company |
| Condition | Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-04-15 |
Trial Parameters
Eligibility Fast-Check
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Brief 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
Eligibility Criteria
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 study participation (prior to 30 days of Screening) will be allowed at the discretion of an investigator. 5. 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. 6. Agrees to smoke the same UB cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand and style currently s