Tolcapone Treatment of Pathological Gambling
This study has been completed.
Information provided by (Responsible Party):
Jon Grant, University of Chicago
First received: June 12, 2009
Last updated: January 17, 2014
Last verified: January 2014
The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in pathological gambling.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Tolcapone Treatment of Pathological Gambling: An Open-Label Study
Primary Outcome Measures:
Secondary Outcome Measures:
- Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) [ Time Frame: Visit 5 (final visit) ] [ Designated as safety issue: No ]
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.
- Gambling Symptom Assessment Scale (G-SAS) [ Time Frame: Visit 5 (final visit) ] [ Designated as safety issue: No ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2012 (Final data collection date for primary outcome measure)
pill, 100-300mg/day for 8 weeks
Other Name: Brand name: TASMAR
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.
|Ages Eligible for Study:
||21 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00927563
|Ambulatory Research Center
|Minneapolis, Minnesota, United States, 55454 |
University of Chicago
||Jon E Grant, MD, JD
||University of Minnesota - Clinical and Translational Science Institute
No publications provided by University of Chicago
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Jon Grant, Professor of Psychiatry, University of Chicago
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 12, 2009
|Results First Received:
||September 11, 2013
||January 17, 2014
||United States: Institutional Review Board
Keywords provided by University of Chicago:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 21, 2014
Impulse Control Disorders
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action