Vigabatrin Ph 1 Cocaine Interaction Study

Phase 1

Completed

• Conditions: Cocaine Addiction
• Interventions: Drug: Matching placebo; Drug: Vigabatrin

• Registration Number: NCT00626834
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief 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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-18
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-02-29
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2016-08
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Exclusion Criteria

Please contact site for more information.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching placebo	Matching placebo	-
Vigabatrin Dose 1	Vigabatrin	-
Vigabatrin Dose 2	Vigabatrin	-
Vigabatrin Dose 3	Vigabatrin	-

Primary Outcome Measures

Name	Time	Method
safety/tolerability and AE assessments including HR/BP/ECG/QTc	56 days

Secondary Outcome Measures

Name	Time	Method
VGB/PK during cocaine infusions and effect of VGB on cocaine craving	28 days

Trial Locations

Locations (1)

University of Texas Health Science Center; 🇺🇸 San Antonio, Texas, United States