Vigabatrin Ph 1 Cocaine Interaction Study

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00626834

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Addiction	Drug: Vigabatrin Drug: Vigabatrin Drug: Vigabatrin Drug: Matching placebo	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vigabatrin Dose 1	Drug: Vigabatrin Dose 1 BID
Experimental: Vigabatrin Dose 2	Drug: Vigabatrin Dose 2 BID
Experimental: Vigabatrin Dose 3	Drug: Vigabatrin Dose 3 BID
Placebo Comparator: Matching placebo	Drug: Matching placebo Matching placebo BID

Outcome Measures

Primary Outcome Measures

safety/tolerability and AE assessments including HR/BP/ECG/QTc [56 days]

Secondary Outcome Measures

VGB/PK during cocaine infusions and effect of VGB on cocaine craving [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center	San Antonio	Texas	United States	78229

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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)