Vigabatrin for Treatment of Cocaine Dependence

Completed · Phase 2 · Has a placebo group

Conditions studied: Cocaine Dependence

In brief

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.

Key facts

Study ID

NCT00611130

Run by

Catalyst Pharmaceuticals, Inc.

People needed

186

Starts

2008-01-01

Expected to finish

2012-10-01

Last updated by the study team

2016-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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