Tolcapone Treatment of Pathological Gambling

Inclusion Criteria

• Men and women age 21-75;
• 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);
• Gambling behavior within 2 weeks prior to enrollment;
• Women of child bearing age are required to have a negative result on a beta-human chorionic gonadotropin pregnancy test;
• 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

• Infrequent gambling (i.e. less than one time per week) that does not meet DSM-IV criteria for PG;
• Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen as determined by the investigator;
• History of elevated liver enzymes (AST/ALT) or other liver abnormalities;
• History of seizures;
• Myocardial infarction within 6 months;
• Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
• A need for medication other than tolcapone with possible psychotropic effects or unfavorable interactions as determined by the investigator;
• Clinically significant suicidality (defined as score 2 or higher on HAM-D item 3);
• Current co-morbid Axis I disorder determined by the Structured Clinical Interview for DSM-IV (SCID), (First et al., 1995) - except for nicotine dependence;
• Lifetime history of bipolar disorder type I or II, schizophrenia, or any psychotic disorder determined by SCID;
• Clinically significant cognitive impairment (defined as score less than 88 on 3MS);
• Current or recent (past 3 months) DSM-IV substance abuse or dependence;
• Positive urine drug screen at screening;
• Initiation of psychotherapy or behavior therapy for pathological gambling within 3 months prior to study baseline;
• Previous treatment with tolcapone;
• Treatment with an investigational medication or depot neuroleptics within 3 months;
• Refusal to sign the tolcapone information sheet.