NCT00626834

Vigabatrin Ph 1 Cocaine Interaction Study

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 safety/tolerably study to determine if there are clinically significant interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent with intravenous (IV) cocaine infusions.

Detailed description

STUDY DESIGN: This is a randomized, double-blind, placebo-controlled, parallel group study of the effects of VGB compared to placebo control on the physiological and subjective effects of IV infusions of cocaine (cocaine experienced volunteers). Subjects will be randomized within each clinical site to one of four groups (placebo control or one of three doses of VGB twice daily).During VGB steady state dosing, subjects will receive double-blind infusions of saline and cocaine. Subjects will be asked to return for follow-up approximately 7 and 14 days after the day of clinic discharge. STUDY DURATION: The maximum duration is 56 days, including 14 inpatient days of assessments and investigational products administration, and two follow-up visits after clinic discharge. SAMPLE SIZE: Twenty-four subjects will be randomized to one of three doses of vigabatrin or placebo. POPULATION: Volunteer, cocaine-experienced, non-treatment seeking cocaine users, 18 to 45 years of age.

Conditions

• Cocaine Addiction

Interventions

Type	Name	Description
DRUG	Vigabatrin	Dose 1 BID
DRUG	Vigabatrin	Dose 2 BID
DRUG	Vigabatrin	Dose 3 BID
DRUG	Matching placebo	Matching placebo BID

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2008-02-29
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States