Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT01075659
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2010-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge
Sponsor:
McNeil AB
Organization:
Study Overview
Official Title:
Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge: A Study in Healthy Smokers
Status:
COMPLETED
Status Verified Date:
2012-07
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:
A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.
Detailed Description:
This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 2 mg and 4 mg, respectively, after 5 hours of witnessed nicotine abstinence with respect to urges to smoke during the first 5 minutes after start of treatment. Single doses of each treatment are given during separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 200 healthy smokers between 19-55 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion, and who smoke within 30 minutes of waking up. Subjects, study personnel and monitor will be aware of what type of product is administered at a given visit, but not of the administered dose of the lozenge.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: