Vigabatrin for Treatment of Cocaine Dependence

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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.

Investigators

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

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Somoza EC, Winship D, Gorodetzky CW, Lewis D, Ciraulo DA, Galloway GP, Segal SD, Sheehan M, Roache JD, Bickel WK, Jasinski D, Watson DW, Miller SR, Somoza P, Winhusen T. A multisite, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of vigabatrin for treating cocaine dependence. JAMA Psychiatry. 2013 Jun;70(6):630-7. doi: 10.1001/jamapsychiatry.2013.872.

Berezina TL, Khouri AS, Winship MD, Fechtner RD. Visual field and ocular safety during short-term vigabatrin treatment in cocaine abusers. Am J Ophthalmol. 2012 Aug;154(2):326-332.e2. doi: 10.1016/j.ajo.2012.02.026. Epub 2012 Jun 15.

Responsible Party:	Catalyst Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00611130 History of Changes
Other Study ID Numbers:	CPP-01004
First Posted:	February 8, 2008
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.:

Cocaine; Addiction; Dependence; Treatment

Additional relevant MeSH terms:

Cocaine-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Cocaine; Vigabatrin; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents	Peripheral Nervous System Agents; Vasoconstrictor Agents; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents; Anticonvulsants; Enzyme Inhibitors; GABA Agents