Vigabatrin Ph 1 Cocaine Interaction Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00626834
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : January 12, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cocaine Addiction Drug: Vigabatrin Drug: Matching placebo Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study
Study Start Date : February 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Vigabatrin Dose 1 Drug: Vigabatrin
Dose 1 BID

Experimental: Vigabatrin Dose 2 Drug: Vigabatrin
Dose 2 BID

Experimental: Vigabatrin Dose 3 Drug: Vigabatrin
Dose 3 BID

Placebo Comparator: Matching placebo Drug: Matching placebo
Matching placebo BID

Primary Outcome Measures :
  1. safety/tolerability and AE assessments including HR/BP/ECG/QTc [ Time Frame: 56 days ]

Secondary Outcome Measures :
  1. VGB/PK during cocaine infusions and effect of VGB on cocaine craving [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00626834

United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: John D. Roache, Ph.D. University of Texas
Principal Investigator: Nora Chiang, Ph.D. National Institute on Drug Abuse (NIDA)
Principal Investigator: Ahmed Elkashef, M.D. National Institute on Drug Abuse (NIDA)
Principal Investigator: Roberta Kahn, M.D. National Institute on Drug Abuse (NIDA)

Responsible Party: National Institute on Drug Abuse (NIDA) Identifier: NCT00626834     History of Changes
Other Study ID Numbers: OV-1014
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine addiction
ovation pharmaceuticals
cocaine related disorders
behavior addictive
mental disorders
therapeutic uses
physiologic effects of drugs
disorder of environmental origin
central nervous system stimulants
central nervous system agents
pharmacological actions
substance related disorders

Additional relevant MeSH terms:
Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Stimulants
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Enzyme Inhibitors
GABA Agents