Tolcapone Treatment of Pathological Gambling

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Tolcapone

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.