Status:
COMPLETED
Vigabatrin for Treatment of Cocaine Dependence
Lead Sponsor:
Catalyst Pharmaceuticals, Inc.
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00611130
Start Date
January 1 2008
End Date
October 1 2012
Last Update
April 13 2016
Active Locations (11)
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1
Addiction Treatment Clinic
Little Rock, Arkansas, United States
2
St. Luke's Hospital Addiction Pharmacology Research Laboratory
San Francisco, California, United States, 94110
3
Friends Research Institute
Torrance, California, United States
4
Operation PAR
Largo, Florida, United States