Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-27 @ 1:23 PM
Study NCT ID:
NCT00606892
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2008-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Varenicline and Nicotine Interactions in Humans (VA)
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Varenicline Attenuates Some of the Subjective and Physiological Effects of Intravenous Nicotine in Humans.
Status:
COMPLETED
Status Verified Date:
2014-09
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:
To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. We predict that varenicline treatment will modify subjective, physiological and cognitive responses to IV nicotine.
Detailed Description:
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will have two 4-day treatment periods, in which they will be randomized to varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers will have daily clinic visits and receive their study medication. On Day 4, subjects will come to the laboratory, where they will receive ascending doses of intravenous (IV) nicotine (0.1, 0.4, and 0.7 mg per 70kg). This procedure will allow accurate assessment of varenicline effects on the subjective, physiological and cognitive responses to nicotine. Following a washout period, subjects will be crossed over to the alternative treatment.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MIRECC 000000000 | REGISTRY | Department of Veteran's Affairs | View | |
| DPMC | OTHER | NIDA | View | |
| R01DA014537 | NIH | None | https://reporter.nih.gov/quic… | View |