This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Vigabatrin Ph 1 Cocaine Interaction Study

This study has been completed.
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA) Identifier:
First received: February 18, 2008
Last updated: January 11, 2017
Last verified: August 2016
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 Intervention Phase
Cocaine Addiction Drug: Vigabatrin Drug: Matching placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by National Institute on Drug Abuse (NIDA):

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

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

Enrollment: 24
Study Start Date: February 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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:

Please contact site for more information.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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)
  More Information

Responsible Party: National Institute on Drug Abuse (NIDA) Identifier: NCT00626834     History of Changes
Other Study ID Numbers: OV-1014
Study First Received: February 18, 2008
Last Updated: January 11, 2017
Individual Participant Data  
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 processed this record on June 23, 2017