Vigabatrin for Treatment of Cocaine Dependence

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catalyst Pharmaceuticals, Inc.
• Treatments: Cocaine; Vigabatrin

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.