Vigabatrin Ph 1 Cocaine Interaction Study

Study Overview
=================
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 (IV) cocaine infusions.

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.

Official Title
-----------------
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study

Conditions
-----------------
Cocaine Addiction

Intervention / Treatment
-----------------
* Drug: Vigabatrin
* Drug: Vigabatrin
* Drug: Vigabatrin
* Drug: Matching placebo


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vigabatrin Dose 1<br> | Drug: Vigabatrin<br>* Dose 1 BID<br>|
| Experimental: Vigabatrin Dose 2<br> | Drug: Vigabatrin<br>* Dose 2 BID<br>|
| Experimental: Vigabatrin Dose 3<br> | Drug: Vigabatrin<br>* Dose 3 BID<br>|
| Placebo Comparator: Matching placebo<br> | Drug: Matching placebo<br>* Matching placebo BID<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety/tolerability and AE assessments including HR/BP/ECG/QTc |  | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VGB/PK during cocaine infusions and effect of VGB on cocaine craving |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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