Tolcapone Treatment of Pathological Gambling

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

Detailed Description
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The proposed study will consist of 8 weeks of treatment with tolcapone in 10 subjects with pathological gambling. The hypothesis to be tested is that tolcapone will be effective in reducing the urges to gamble in patients with pathological gambling. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Official Title
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Tolcapone Treatment of Pathological Gambling: An Open-Label Study

Conditions
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Pathological Gambling

Intervention / Treatment
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* Drug: Tolcapone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tolcapone<br>Tolcapone 100-300mg/day | Drug: Tolcapone<br>* pill, 100-300mg/day for 8 weeks<br>* Other names: Brand name: TASMAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scale (CGI) | The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is assessed at every visit (1-5), but only the final visit will be reported here. | Visit 5 (final visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) | Scale used to measure severity of gambling. Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The PG-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. | Visit 5 (final visit) | 
| Gambling Symptom Assessment Scale (G-SAS) | Self report test of severity of gambling on a scale from 0-48 with 48 being the most severe. The G-SAS was performed at every visit (1-5), but only the final visit (visit 5) will be reported here as a final score. | Visit 5 (final visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gambling, Addiction