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Vigabatrin for Treatment of Cocaine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00611130
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : June 12, 2012
Last Update Posted : April 13, 2016
Information provided by (Responsible Party):
Catalyst Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: vigabatrin Drug: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
Study Start Date : January 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Vigabatrin

Arm Intervention/treatment
Experimental: 1
3 Vigabatrin Tablets, 500 mg, bid, for 9 weeks
Drug: vigabatrin
Tablets twice a day for 9 weeks
Other Name: CPP-109, VGB, GVG

Placebo Comparator: 2
3 Placebo Tablets, bid, for 9 weeks
Drug: placebo
tablets twice daily for 9 weeks

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00611130

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United States, Arkansas
Addiction Treatment Clinic
Little Rock, Arkansas, United States
United States, California
St. Luke's Hospital Addiction Pharmacology Research Laboratory
San Francisco, California, United States, 94110
Friends Research Institute
Torrance, California, United States
United States, Florida
Operation PAR
Largo, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
United States, Maryland
Johns Hopkins Bayview Medical Center Center for Chemical Dependence
Baltimore, Maryland, United States
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States
United States, New York
New York University Mental Health and Addictive Disorders Research Program
New York, New York, United States
United States, Ohio
Cincinnati Addiction Research Center (CinARC)
Cincinnati, Ohio, United States
Dayton Veterans Affairs Medical Center
Dayton, Ohio, United States
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Sponsors and Collaborators
Catalyst Pharmaceuticals, Inc.
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Principal Investigator: Eugene Somoza, MD, PhD University of Cincinnati
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Catalyst Pharmaceuticals, Inc. Identifier: NCT00611130    
Other Study ID Numbers: CPP-01004
First Posted: February 8, 2008    Key Record Dates
Results First Posted: June 12, 2012
Last Update Posted: April 13, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Catalyst Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs