NCT03126357

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	Product A	Usual Brand Cigarette
OTHER	Product B	FT21039 an electronic tobacco vapor product
OTHER	Product C	FT21092 an electronic tobacco vapor product
OTHER	Product D	FT21018 an electronic tobacco vapor product
OTHER	Product E	4mg nicotine gum

Timeline

• Start date: 2017-04-17
• Primary completion: 2017-05-25
• Completion: 2017-05-25
• First posted: 2017-04-24
• Last updated: 2017-06-27

Locations

1 site across 1 country: United States