Effects of Phenytoin on Cocaine Use in Humans - 2

Cocaine-Related Disorders Clinical Trial

Official title: Effects of Phenytoin on Cocaine Use in Humans

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the effects of phenytoin on the self-administration of smoked cocaine.

Clinical Trial 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 (20mg/kg) aimed at achieving plasma phenytoin concentration of (10-20 mg/L). 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 Design

Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

• NCT number: NCT00000285
• Study type: Interventional
• Source: National Institute on Drug Abuse (NIDA)
• Status: Completed
• Phase: Phase 1
• Start date: May 1996
• Completion date: December 2001