Vigabatrin for Treatment of Cocaine Dependence

NCT ID: NCT00611130

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-10-31

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.

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.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

3 Vigabatrin Tablets, 500 mg, bid, for 9 weeks

Group Type: EXPERIMENTAL

vigabatrin

Intervention Type: DRUG

Tablets twice a day for 9 weeks

2

3 Placebo Tablets, bid, for 9 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

tablets twice daily for 9 weeks

Interventions

vigabatrin

Tablets twice a day for 9 weeks

Intervention Type: DRUG

placebo

tablets twice daily for 9 weeks

Intervention Type: DRUG

Other Intervention Names

CPP-109, VGB, GVG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catalyst Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugene Somoza, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

Addiction Treatment Clinic

Little Rock, Arkansas, United States

St. Luke's Hospital Addiction Pharmacology Research Laboratory

San Francisco, California, United States

Friends Research Institute

Torrance, California, United States

Operation PAR

Largo, Florida, United States

Segal Institute for Clinical Research

North Miami, Florida, United States

Johns Hopkins Bayview Medical Center Center for Chemical Dependence

Baltimore, Maryland, United States

Boston University School of Medicine

Boston, Massachusetts, United States

New York University Mental Health and Addictive Disorders Research Program

New York, New York, United States

Cincinnati Addiction Research Center (CinARC)

Cincinnati, Ohio, United States

Dayton Veterans Affairs Medical Center

Dayton, Ohio, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23575810 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22704138 (View on PubMed)

Other Identifiers

CPP-01004

Identifier Type: -

Identifier Source: org_study_id