Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

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.

Intervention(s) in this Clinical Trial

• Drug: vigabatrin
  • Tablets twice a day for 12 weeks
• Drug: vigabatrin
  • tablets twice daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Vigabatrin Tablets
• Placebo Comparator: 2
  • Placebo Tablets

Primary Measures

• The primary outcome variable is the proportion of subjects in each treatment group who are abstinent during the last 2 weeks of treatment.
  • Time Frame: Week 13
    Safety Issue?: No

Secondary Measures

• Group differences in the weekly fraction of cocaine use days divided by the sum of cocaine use and non-use days, for each of the 2 baseline weeks and for Treatment Phase Weeks 1 through 12.
  • Time Frame: 12 Weeks
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Catalyst Pharmaceutical Partners, Inc

Overall Clinical Trial Officials and Contacts

Eugene Somoza, MD, PhD Principal Investigator University of Cincinnati  

Overall Contact: M Douglas Winship 305-529-2522 dwinship@catalystpharma.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00611130

Study ID Number: CPP-01004

ClinicalTrials.gov Identifier: NCT00611130

Health Authority: United States: Food and Drug Administration