Vigabatrin for Treatment of Cocaine Dependence

March 14, 2016 updated by: Catalyst Pharmaceuticals, Inc.

Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study

The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be cocaine-free in the last 2 weeks of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cocaine addiction, a serious public health concern associated with significant medical, social, and economic consequences, is difficult to treat using traditional psychosocial and behavioral therapies. Despite testing of a number of different agents for cocaine dependency, there remains no proven pharmacologic treatment for cocaine addiction.

The addictive properties of cocaine have been associated with its actions on mesotelencephalic dopamine reward pathways in the central nervous system (CNS). Cocaine administration increases the levels of dopamine, a neurotransmitter associated with sensations of pleasure and reward. Therefore, blocking cocaine-induced increases in dopamine levels represents a valid pharmaceutical approach to the treatment of cocaine addiction.

Another neurotransmitter, gamma-aminobutyric acid (GABA), suppresses striatal dopamine release, and attenuates cocaine-induced increases in extracellular and synaptic dopamine levels in the striatum and nucleus accumbens in animal models of drug dependence. Significant elevation of brain GABA levels may reduce cocaine-stimulated dopamine release and dampen the sensations of pleasure and reward. Thus, drugs that potentiate or enhance GABA-ergic transmission are candidates for the treatment of cocaine addiction.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Addiction Treatment Clinic
    • California
      • San Francisco, California, United States, 94110
        • St. Luke's Hospital Addiction Pharmacology Research Laboratory
      • Torrance, California, United States
        • Friends Research Institute
    • Florida
      • Largo, Florida, United States
        • Operation PAR
      • North Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins Bayview Medical Center Center for Chemical Dependence
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston University School of Medicine
    • New York
      • New York, New York, United States
        • New York University Mental Health and Addictive Disorders Research Program
    • Ohio
      • Cincinnati, Ohio, United States
        • Cincinnati Addiction Research Center (CinARC)
      • Dayton, Ohio, United States
        • Dayton Veterans Affairs Medical Center
    • Texas
      • San Antonio, Texas, United States
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to understand the study and provide written informed consent.
  • Male or female at least 18 years of age.
  • Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition) criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse module of SCID (Structured Clinical Interview for DSM-IV).
  • Provide at least one urine sample that is positive for cocaine according to a rapid screening test.
  • Seeking treatment for cocaine dependence.
  • Have normal visual fields.
  • Be in generally good health based on history, physical examination, electrocardiogram and laboratory findings.
  • If female of childbearing potential, use acceptable contraceptive methods. (oral contraceptives (the pill), IUDs, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). Surgical sterilization by tubal ligation or hysterectomy is acceptable

Exclusion Criteria:

  • Has current dependence, as determined by the SCID, on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiologic dependence on alcohol requiring medical detoxification.
  • Has any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the Principal Investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk.
  • Be under court mandate to obtain treatment.
  • Be enrolled in an opiate substitution treatment program within 2 months of randomization.
  • Has ever taken vigabatrin in the past.
  • Is pregnant or lactating.
  • Has clinically significant ophthalmologic disease, which would preclude safety monitoring or is undergoing treatment for ocular disease.
  • Has received a drug with known major organ toxicity, including retinotoxicity within 30 days of randomization.
  • Is currently participating in, or has been enrolled in another clinical trial within the last 30 days.
  • Be anyone who, in the judgment of the investigator, would not be expected to attend regular study visits or to complete the study protocol, due to imminent relocation from the clinic area, legal difficulties, work-related problems, transportation, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
3 Vigabatrin Tablets, 500 mg, bid, for 9 weeks
Drug: vigabatrin
Tablets twice a day for 9 weeks
Other Names:
  • CPP-109, VGB, GVG
Placebo Comparator: 2
3 Placebo Tablets, bid, for 9 weeks
Drug: placebo
tablets twice daily for 9 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.
Time Frame: Week 13
Number of subjects in the CPP-109 Vigabatrin Group vs. Number in Placebo Group abstinent from using cocaine during Weeks 11 and 12 of the Treatment Phase.
Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalyst Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Eugene Somoza, MD, PhD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (Estimate)

February 8, 2008

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPP-01004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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