NCT04094363

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Smoking
• Tobacco Smoking
• Tobacco Use

Interventions

Type	Name	Description
OTHER	Product A	Usual Brand, filtered combustible cigarette
OTHER	Product B	CSD1902-11, an electronic nicotine delivery system
OTHER	Product C	CSD1902-21, an electronic nicotine delivery system
OTHER	Product D	4mg Nicotine gum

Timeline

• Start date: 2019-10-03
• Primary completion: 2019-11-26
• Completion: 2019-11-26
• First posted: 2019-09-18
• Last updated: 2022-06-27

Locations

2 sites across 1 country: United States