Tolcapone Treatment of Pathological Gambling
Condition: Pathological Gambling
MeSH terms: Gambling
Intervention: Tolcapone
Intervention description: pill, 100-300mg/day for 8 weeks
Intervention MeSH terms: Tolcapone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Gambling; Addiction

Summary:

      The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in
      pathological gambling.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women age 21-75;

          2. Meet diagnostic criteria for current pathological gambling based on DSM-IV criteria
             and confirmed using the clinician-administered Structured Clinical Interview for
             Pathological Gambling (SCI-PG) (Grant et al., 2004);

          3. Gambling behavior within 2 weeks prior to enrollment;

          4. Women of child bearing age are required to have a negative result on a beta-human
             chorionic gonadotropin pregnancy test;

          5. Women of childbearing potential utilizing a medically accepted form of contraception
             defined as double barrier, oral contraceptive, injectable contraceptive, implantable
             contraceptive devices, and abstinence.

        Exclusion Criteria:

          1. Infrequent gambling (i.e. less than one time per week) that does not meet DSM-IV
             criteria for PG;

          2. Unstable medical illness or clinically significant abnormalities on laboratory tests,
             EKG, or physical examination at screen as determined by the investigator;

          3. History of elevated liver enzymes (AST/ALT) or other liver abnormalities;

          4. History of seizures;

          5. Myocardial infarction within 6 months;

          6. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential;

          7. A need for medication other than tolcapone with possible psychotropic effects or
             unfavorable interactions as determined by the investigator;

          8. Clinically significant suicidality (defined as score 2 or higher on HAM-D item 3);

          9. Current co-morbid Axis I disorder determined by the Structured Clinical Interview for
             DSM-IV (SCID), (First et al., 1995) - except for nicotine dependence;

         10. Lifetime history of bipolar disorder type I or II, schizophrenia, or any psychotic
             disorder determined by SCID;

         11. Clinically significant cognitive impairment (defined as score less than 88 on 3MS);

         12. Current or recent (past 3 months) DSM-IV substance abuse or dependence;

         13. Positive urine drug screen at screening;

         14. Initiation of psychotherapy or behavior therapy for pathological gambling within 3
             months prior to study baseline;

         15. Previous treatment with tolcapone;

         16. Treatment with an investigational medication or depot neuroleptics within 3 months;

         17. Refusal to sign the tolcapone information sheet.