NCT04167384

CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products

CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products During a 6-Day In-Clinic Confinement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) study, designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use of the study investigational products (IPs) by generally healthy subjects.

Detailed description

Cigarette smokers and smokers who also use smokeless tobacco (SST) \[e.g., snus, moist snuff\] will be recruited into the study. Starting on Day -1, eligible subjects will be confined at the clinical site for 6 days. Subjects will be randomized to evaluate one IP in each of five separate Test Sessions, such that each subject will evaluate five IPs: one of two forms of the nicotine lozenge in three different regimens, a commercially-available nicotine replacement therapy (NRT) nicotine lozenge, and the subjects' usual brand (UB) cigarettes. Each Test Session will last for approximately 6 hours during and following IP use and will include collection of subjective measures, PK assessments and physiological measures. On Day -1, subjects will be instructed on how to use both the specific lozenge IP in their assigned study arm and the NRT lozenge and will have one trial use of both IP.

Conditions

• Smoking
• Tobacco Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	Product A	Usual brand (UB) filtered, combustible cigarette
OTHER	Product B	Nicorette® Mint 4 mg nicotine lozenge
OTHER	Product C	CSD1903-11, a hard nicotine lozenge, 2 mg nicotine
OTHER	Product D	CSD1903-11, a hard nicotine lozenge, 4 mg nicotine
OTHER	Product E	CSD1903-11, a hard nicotine lozenge, 8 mg nicotine
OTHER	Product F	CSD1903-12, a soft nicotine lozenge, 2 mg nicotine
OTHER	Product G	CSD1903-12, a soft nicotine lozenge, 4 mg nicotine
OTHER	Product H	CSD1903-12, a soft nicotine lozenge, 8 mg nicotine

Timeline

• Start date: 2019-12-02
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2019-11-18
• Last updated: 2020-03-12

Locations

1 site across 1 country: United States