Status:
COMPLETED
Vigabatrin Ph 1 Cocaine Interaction Study
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Addiction
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 (...
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...
Eligibility Criteria
Inclusion
- 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
- Please contact site for more information.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00626834
Start Date
February 1 2008
End Date
October 1 2010
Last Update
January 12 2017
Active Locations (1)
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1
University of Texas Health Science Center
San Antonio, Texas, United States, 78229