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Vigabatrin Ph 2a Cocaine Interaction Study
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), June 2009
First Received: February 18, 2008   Last Updated: June 17, 2009   History of Changes
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00626834
  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 II

Study Type: Interventional
Study Design: Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:


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
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vigabatrin Dose 1: Experimental Drug: Vigabatrin
Dose 1 BID
Vigabatrin Dose 2: Experimental Drug: Vigabatrin
Dose 2 BID
Vigabatrin Dose 3: Experimental Drug: Vigabatrin
Dose 3 BID
Matching placebo: Placebo Comparator 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

Contacts
Contact: Jurij Mojsiak 301-443-9804 jm200p@nih.gov
Contact: Liza Gorgon 301-443-1138 lgorgon@nih.gov

Locations
United States, Texas
University of Texas Health Science Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Bill Murff     210-358-1279     murff@uthscsa.edu    
Contact: Alex Carrizales     210-358-1211     carrizalesf@uthscsa.edu    
Principal Investigator: John D Roache, Ph.D.            
Sponsors and Collaborators
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: University of Texas ( John Roache, Ph.D. )
Study ID Numbers: OV-1014
Study First Received: February 18, 2008
Last Updated: June 17, 2009
ClinicalTrials.gov Identifier: NCT00626834     History of Changes
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

Study placed in the following topic categories:
Dopamine Uptake Inhibitors
Cocaine-Related Disorders
Neurotransmitter Agents
Behavior, Addictive
Vigabatrin
Central Nervous System Depressants
Anesthetics
Disorders of Environmental Origin
Central Nervous System Stimulants
Cardiovascular Agents
Anesthetics, Local
Dopamine
Mental Disorders
Gamma-Aminobutyric Acid
Substance-Related Disorders
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Cocaine
Anticonvulsants

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Vigabatrin
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Anesthetics
Mental Disorders
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Substance-Related Disorders
Cocaine
Cocaine-Related Disorders
Central Nervous System Depressants
Central Nervous System Stimulants
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Anesthetics, Local
GABA Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on July 02, 2009