Vigabatrin Ph 2a Cocaine Interaction Study

This study has been completed.

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00626834

First received: February 18, 2008

Last updated: November 3, 2010

Last verified: November 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 18, 2008

Last Updated Date

November 3, 2010

Start Date ^ICMJE

February 2008

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

safety/tolerability and AE assessments including HR/BP/ECG/QTc [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00626834 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

VGB/PK during cocaine infusions and effect of VGB on cocaine craving [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Vigabatrin Ph 2a Cocaine Interaction Study

Official Title ^ICMJE

A Phase 2A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study

Brief Summary

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Cocaine Addiction

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00626834

Other Study ID Numbers ^ICMJE

OV-1014

Has Data Monitoring Committee

Yes

Responsible Party

John Roache, Ph.D., University of Texas

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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)

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

November 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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