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”

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 Type: Interventional

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

Study Primary Completion Date: February 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Vigabatrin
  • Dose 1 BID
• Drug: Vigabatrin
  • Dose 2 BID
• Drug: Vigabatrin
  • Dose 3 BID
• Drug: Matching placebo
  • Matching placebo BID

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Drug: Vigabatrin Dose 1
• Experimental: 2
  • Drug Vigabatrin Dose 2
• Experimental: 3
  • Drug Vigabatrin Dose 3
• Placebo Comparator: 4
  • Matching placebo

Primary Measures

• safety/tolerability and AE assessments including HR/BP/ECG/QTc
  • Time Frame: 56 days
    Safety Issue?: Yes

Secondary Measures

• VGB/PK during cocaine infusions and effect of VGB on cocaine craving
  • Time Frame: 28 days
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Be between 18 and 45 years of age, inclusive.
• 2. Currently be a non-treatment seeking cocaine user as confirmed by a positive urine test for cocaine.
• 3. Able to provide written informed consent.
• 4. A negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine.

Exclusion Criteria:

• Please contact site for more information.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ovation Pharmaceuticals

Overall Clinical Trial Officials and Contacts

John D. Roache, Ph.D. Principal Investigator University of Texas  

Overall Contact: Rick McVey 847-282-5728 rmcvey@ovationpharma.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00626834

Study ID Number: OV-1014

ClinicalTrials.gov Identifier: NCT00626834

Health Authority: United States: Food and Drug Administration