Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000285
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
1999-09-20
Brief Title:
Effects of Phenytoin on Cocaine Use in Humans - 2
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Effects of Phenytoin on Cocaine Use in Humans
Status:
COMPLETED
Status Verified Date:
2016-11
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:
The purpose of this study is to determine the effects of phenytoin on the self-administration of smoked cocaine
Detailed Description:
The purpose of this study was to determine the effects of phenytoin on smoked cocaine-base self-administration using our laboratory self-administration model A total of 12 patients randomized 6 to phenytoin and 6 to placebo treatment group There were 2 phases in this 10-day inpatient study Phase 1 subjects underwent one cocaine self-admin session Randomization took place at the start of Phase 2 Day 4 where subjects received either placebo or phenytoin The subjects assigned to phenytoin treatment received an oral loading dose 20mgkg aimed at achieving plasma phenytoin concentration of 10-20 mgL During Phase 2 subjects had the opportunity to self-administer cocaine on Days 5 7 and 9 The plasma phenytoin levels were expected to decrease gradually during Phase 2 which provided an opportunity to study the effect of decreasing phenytoin plasma concentrations on cocaine self-administration
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50-09259-2 | None | None | None |