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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04094363
Other study ID # CSD190202
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 3, 2019
Est. completion date November 26, 2019

Study information

Verified date June 2022
Source RAI Services Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States New Orleans Center for Clinical Research (NOCCR) Knoxville Tennessee
United States ICON Clinical Research San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
RAI Services Company ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUECPL 10-240 Area under the product liking (PL) NRS score-versus-time curve from 10 minutes to 240 minutes after the start of investigational product (IP) use. 3, 5, 10, 15, 30, 45, 60, 90, 180, and 240 minutes
Primary Emax PL Maximum response for product effects with regards to PL score after the start of IP use. 3, 5, 10, 15, 30, 45, 60, 90, 180, and 240 minutes
Primary Eoverall IUA Overall intent to use again (IUA), measured at 240 minutes after the start of IP use. 240 minutes
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