Tolcapone Treatment of Pathological Gambling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00927563
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Information provided by (Responsible Party):
Jon Grant, University of Chicago

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

Condition or disease Intervention/treatment Phase
Pathological Gambling Drug: Tolcapone Phase 2

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tolcapone Treatment of Pathological Gambling: An Open-Label Study
Study Start Date : June 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Tolcapone

Arm Intervention/treatment
Experimental: Tolcapone
Tolcapone 100-300mg/day
Drug: Tolcapone
pill, 100-300mg/day for 8 weeks
Other Name: Brand name: TASMAR

Primary Outcome Measures :
  1. Clinical Global Impression Scale (CGI) [ Time Frame: Visit 5 (final visit) ]
    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.

Secondary Outcome Measures :
  1. Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) [ Time Frame: Visit 5 (final visit) ]
    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.

  2. Gambling Symptom Assessment Scale (G-SAS) [ Time Frame: Visit 5 (final visit) ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00927563

United States, Minnesota
Ambulatory Research Center
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Chicago
Principal Investigator: Jon E Grant, MD, JD University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jon Grant, Professor of Psychiatry, University of Chicago Identifier: NCT00927563     History of Changes
Other Study ID Numbers: 0901M58441
First Posted: June 25, 2009    Key Record Dates
Results First Posted: March 6, 2014
Last Update Posted: March 6, 2014
Last Verified: January 2014

Keywords provided by Jon Grant, University of Chicago:

Additional relevant MeSH terms:
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action