CSD190202: Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems

Smoking Clinical Trial

Official title: CSD190202: A Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems

Status Completed

Clinical Trial Summary

This is a randomized, open-label, crossover 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 investigational products (IPs) by healthy subjects.

Clinical Trial Description

The study will recruit smokers of combustible cigarettes.

Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility within 45 days prior to enrollment.

Starting on Day 1, eligible smokers will be confined at the clinical site for 9 days. Subjects will participate in four separate Test Sessions for AL assessment, one for each IP. Each Test Session will last for approximately 4 hours during and following IP use. Subjects will be randomized to use one IP in each Test Session: Usual Brand (UB) combustible cigarettes, nicotine gum, and 2 Electronic Nicotine Delivery Systems (ENDS).

For approximately a day and a half prior to each respective Test Session, IP will be dispensed for ad libitum use for product familiarization. ;

Related Conditions & MeSH terms

• Smoking
• Tobacco Smoking
• Tobacco Use

• NCT number: NCT04094363
• Study type: Interventional
• Source: RAI Services Company
• Status: Completed
• Phase: N/A
• Start date: October 3, 2019
• Completion date: November 26, 2019