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Completed

NCT Number: NCT00626834

Vigabatrin Ph 1 Cocaine Interaction Study

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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Key information

Conditions

Cocaine Addiction Behavior Behavior, Addictive Chemically-Induced Disorders Cocaine-Related Disorders Compulsive Behavior Impulsive Behavior Mental Disorders Substance-Related Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vigabatrin

Drug

Dose 1 BID

Matching Placebo

Drug

Matching placebo BID

Primary outcomes

  1. safety/tolerability and AE assessments including HR/BP/ECG/QTc

    Time frame: 56 days

Secondary outcomes

  1. VGB/PK during cocaine infusions and effect of VGB on cocaine craving

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 29, 2008
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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