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Vigabatrin Ph 2a Cocaine Interaction Study

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00626834
First received: February 18, 2008
Last updated: November 3, 2010
Last verified: November 2010
History of Changes
  Purpose

This is a Phase 2a 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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 2A 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626834

Locations
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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

No publications provided

Responsible Party: John Roache, Ph.D., University of Texas
ClinicalTrials.gov Identifier: NCT00626834     History of Changes
Other Study ID Numbers: OV-1014
Study First Received: February 18, 2008
Last Updated: November 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine addiction
vigabatrin
ovation pharmaceuticals
cocaine
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
Mental Disorders
Central Nervous System Stimulants
Central Nervous System Agents
Cocaine
Vigabatrin
Gamma-Aminobutyric Acid
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Vasoconstrictor Agents
 Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
GABA Agents
Enzyme Inhibitors
Anticonvulsants

ClinicalTrials.gov processed this record on June 17, 2013