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CSD170401: Study to Assess Elements of Abuse Liability for Three Electronic Tobacco Vapor Products During an 11-Day In-Clinic Confinement

Smoking Clinical Trial

Official title:
CSD170401: A Single-Center, Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Three Electronic Tobacco Vapor Products During an 11-Day In-Clinic Confinement

Clinical Trial Summary

This study will examine elements of abuse liability (AL) related to potential product adoption of three electronic tobacco vapor products by current smokers relative to high and low AL comparator products (usual brand cigarette and nicotine gum, respectively). Changes in subjective measures, speed and amount of nicotine uptake, and maximum changes in physiological effects during and after product use that follows a 12-hour (minimum) tobacco and nicotine abstinence period, will be determined. The electronic tobacco vapor products will not be compared to each other.

Clinical Trial Description

This is a single-center, randomized, open-label, crossover study, designed to evaluate subjective effects (i.e., Product Liking [PL], Overall Intent to Use Again [OIUA], Product Effects [PE], Urge to Smoke [UTS], and Overall Product Liking [OPL]), plasma nicotine uptake, and physiological measures (blood pressure and heart rate) during and following ad libitum use of the following five IPs by healthy subjects. Subjects will be evaluated in five separate Test Sessions and the active period of each Test Session will last for approximately 4 hours during and following IP use. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03126357
Study type Interventional
Source RAI Services Company
Contact
Status Completed
Phase N/A
Start date April 17, 2017
Completion date May 25, 2017
View Details
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