Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Tolcapone Treatment of Pathological Gambling

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago
ClinicalTrials.gov Identifier:
NCT00927563
First received: June 12, 2009
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Pathological Gambling
Drug: Tolcapone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tolcapone Treatment of Pathological Gambling: An Open-Label Study

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Clinical Global Impression Scale (CGI) [ Time Frame: Visit 5 (final visit) ] [ Designated as safety issue: No ]
    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:
  • 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.


Enrollment: 24
Study Start Date: June 2009
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolcapone
Tolcapone 100-300mg/day
Drug: Tolcapone
pill, 100-300mg/day for 8 weeks
Other Name: Brand name: TASMAR

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927563

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

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jon Grant, Professor of Psychiatry, University of Chicago
ClinicalTrials.gov Identifier: NCT00927563     History of Changes
Other Study ID Numbers: 0901M58441
Study First Received: June 12, 2009
Results First Received: September 11, 2013
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Gambling
Addiction

Additional relevant MeSH terms:
Gambling
Impulse Control Disorders
Mental Disorders
Tolcapone
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014