Vigabatrin for Treatment of Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: vigabatrin; placebo
Intervention description: Tablets twice a day for 9 weeks; tablets twice daily for 9 weeks
Intervention MeSH terms: Vigabatrin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cocaine; Addiction; Dependence; Treatment

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.
    

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.