Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-22 @ 6:43 PM
Study NCT ID:
NCT03126357
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2017-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CSD170401: Study to Assess Elements of Abuse Liability for Three Electronic Tobacco Vapor Products During an 11-Day In-Clinic Confinement
Sponsor:
RAI Services Company
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: