Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-27 @ 11:15 AM
Study NCT ID:
NCT02193269
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2014-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Minocycline in Humans
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Cognitive Effects of Minocycline in Humans
Status:
COMPLETED
Status Verified Date:
2019-09
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 determine minocycline's effects on cognitive performance and measures of mood in abstinent cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric oxide (NO) production. Previous animal and human studies suggest that minocycline may have utility as a treatment for cocaine addiction.
Detailed Description:
We are proposing a randomized, double-blind, crossover study. A total of 40 male and or female subject completers will have two 4-day treatment periods, in which they will be randomized to minocycline (200 mg/day) or placebo. During the first 3 days of each treatment period, subjects will have daily clinic visits for medication administration and monitoring of adverse events. On Day 4, subjects will have an experimental session in which measures of mood and cognitive performance will be obtained. Following a washout period, ranging from 5 to 15 days, subjects will be crossed over to the alternative treatment.
This study began July 2013; currently 7 subjects were randomized with 5 completers and two drop outs. This study is in data analysis phase.
This study began July 2013; currently 7 subjects were randomized with 5 completers and two drop outs. This study is in data analysis phase.
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?: