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

Smoking Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Smoking
• Tobacco Smoking
• Tobacco Use

• NCT number: NCT04167384
• Study type: Interventional
• Source: RAI Services Company
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Completion date: February 28, 2020