Back to resultsTolcapone Treatment of Pathological Gambling
Primary Purpose
Pathological Gambling
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tolcapone
Sponsored by
About this trial
This is an interventional treatment trial for Pathological Gambling focused on measuring Gambling, Addiction
Eligibility Criteria
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.
Sites / Locations
- Ambulatory Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tolcapone
Arm Description
Tolcapone 100-300mg/day
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00927563
Brief Title
Tolcapone Treatment of Pathological Gambling
Official Title
Tolcapone Treatment of Pathological Gambling: An Open-Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling
Keywords
Gambling, Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tolcapone
Arm Type
Experimental
Arm Description
Tolcapone 100-300mg/day
Intervention Type
Drug
Intervention Name(s)
Tolcapone
Other Intervention Name(s)
Brand name: TASMAR
Intervention Description
pill, 100-300mg/day for 8 weeks
Primary Outcome Measure Information:
Title
Clinical Global Impression Scale (CGI)
Description
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.
Time Frame
Visit 5 (final visit)
Secondary Outcome Measure Information:
Title
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)
Description
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.
Time Frame
Visit 5 (final visit)
Title
Gambling Symptom Assessment Scale (G-SAS)
Description
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.
Time Frame
Visit 5 (final visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD, JD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulatory Research Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23953269
Citation
Grant JE, Odlaug BL, Chamberlain SR, Hampshire A, Schreiber LR, Kim SW. A proof of concept study of tolcapone for pathological gambling: relationships with COMT genotype and brain activation. Eur Neuropsychopharmacol. 2013 Nov;23(11):1587-96. doi: 10.1016/j.euroneuro.2013.07.008. Epub 2013 Aug 6.
Results Reference
derived
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Tolcapone Treatment of Pathological Gambling
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