Vigabatrin Ph 1 Cocaine Interaction Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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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

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Cocaine Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Dose 1 BID

Intervention Type DRUG

Vigabatrin

Dose 2 BID

Intervention Type DRUG

Vigabatrin

Dose 3 BID

Intervention Type DRUG

Matching placebo

Matching placebo BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be between 18 and 45 years of age, inclusive
* Currently be a non-treatment seeking cocaine user as confirmed by a positive urine test for cocaine
* Able to provide written informed consent
* A negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine