NCT00000285

Effects of Phenytoin on Cocaine Use in Humans - 2

Effects of Phenytoin on Cocaine Use in Humans

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (planned)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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 (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.

Conditions

• Cocaine-Related Disorders

Interventions

Type	Name	Description
DRUG	Phenytoin

Timeline

• Start date: 1996-05-01
• Completion: 2001-12-01
• First posted: 1999-09-21
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States