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

February 18, 2008
June 17, 2009
February 2008
June 2010   (final data collection date for primary outcome measure)
safety/tolerability and AE assessments including HR/BP/ECG/QTc [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00626834 on ClinicalTrials.gov Archive Site
VGB/PK during cocaine infusions and effect of VGB on cocaine craving [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
 
Vigabatrin Ph 2a Cocaine Interaction Study
A Phase 2A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study

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.

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.

Phase II
Interventional
Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Cocaine Addiction
  • Drug: Vigabatrin
  • Drug: Matching placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
24
December 2010
June 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years to 45 Years
No
Contact: Jurij Mojsiak 301-443-9804 jm200p@nih.gov
Contact: Liza Gorgon 301-443-1138 lgorgon@nih.gov
United States
 
NCT00626834
John Roache, Ph.D., University of Texas
OV-1014
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)
National Institute on Drug Abuse (NIDA)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP