Tolcapone Treatment of Pathological Gambling

Tolcapone Treatment of Pathological Gambling: An Open-Label Study

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

Study Overview

• Status: Completed
• Conditions: Pathological Gambling
• Intervention / Treatment: Drug: Tolcapone

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
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Ambulatory Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tolcapone; Tolcapone 100-300mg/day	Drug: Tolcapone; pill, 100-300mg/day for 8 weeks; Other Names: Brand name: TASMAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Visit 5 (final visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Visit 5 (final visit)
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.	Visit 5 (final visit)

Collaborators and Investigators

• Sponsor: University of Chicago

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 12, 2009
• First Submitted That Met QC Criteria: June 24, 2009
• First Posted (Estimate): June 25, 2009

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Addiction; Gambling
• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Gambling; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antiparkinson Agents; Anti-Dyskinesia Agents; Catechol O-Methyltransferase Inhibitors; Tolcapone
• Other Study ID Numbers: 0901M58441