Vigabatrin Ph 2a Cocaine 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:||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|
- safety/tolerability and AE assessments including HR/BP/ECG/QTc [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
- VGB/PK during cocaine infusions and effect of VGB on cocaine craving [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
|Experimental: Vigabatrin Dose 1||
Dose 1 BID
|Experimental: Vigabatrin Dose 2||
Dose 2 BID
|Experimental: Vigabatrin Dose 3||
Dose 3 BID
|Placebo Comparator: Matching placebo||
Drug: Matching placebo
Matching placebo BID
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.
|United States, Texas|
|University of Texas Health Science Center|
|San Antonio, Texas, United States, 78229|
|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)|