Status:
COMPLETED
Tolcapone Treatment of Pathological Gambling
Lead Sponsor:
University of Chicago
Conditions:
Pathological Gambling
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
Brief Summary
The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in pathological gambling.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00927563
Start Date
June 1 2009
End Date
July 1 2012
Last Update
February 23 2023
Active Locations (1)
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1
Ambulatory Research Center
Minneapolis, Minnesota, United States, 55454