Tolcapone Treatment of Pathological Gambling

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00927563
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 37
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• 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: Jun 1, 2009
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical Global Impression Scale (CGI) [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) [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jon Grant, Professor of Psychiatry, University of Chicago
• ClinicalTrials.gov Identifier: NCT00927563
• Other Study ID Numbers: 0901M58441
• First Posted: Jun 25, 2009
• Last Update Posted: Mar 6, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Jon Grant, Professor of Psychiatry, University of Chicago: Gambling; Addiction
• Additional relevant MeSH terms: Gambling; Tolcapone

Study Results

Participant Flow

Recruitment Details	Subjects were recruited via media advertisement from January 2010 through February 2012 at the University of Minnesota Department of Psychiatry.
Pre-assignment Detail	Subjects could not be using concomitant use of psychotropic medications with possible effects on PG symptoms (i.e. antidepressants, opioid antagonists)(due to possible interference of results) or have had previous treatment with tolcapone.

Arm/Group Title	Tolcapone
Arm/Group Description	Tolcapone 100-300mg/day Tolcapone : pill, 100-300mg/day for 8 weeks
Period Title: Overall Study
STARTED	24
COMPLETED	22
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Tolcapone
Arm/Group Description	Tolcapone 100-300mg/day Tolcapone : pill, 100-300mg/day for 8 weeks
Overall Participants	24
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	24 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.9 (12.9)
Sex: Female, Male (Count of Participants)
Female	14 58.3%
Male	10 41.7%
Region of Enrollment (participants) [Number]
United States	24 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tolcapone
Arm/Group Description	Tolcapone 100-300mg/day Tolcapone : pill, 100-300mg/day for 8 weeks
Measure Participants	22
Mean (Standard Deviation) [units on a scale]	2.88 (1.30)

2. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tolcapone
Arm/Group Description	Tolcapone 100-300mg/day Tolcapone : pill, 100-300mg/day for 8 weeks
Measure Participants	22
Mean (Standard Deviation) [units on a scale]	10.50 (7.02)

3. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tolcapone
Arm/Group Description	Tolcapone 100-300mg/day Tolcapone : pill, 100-300mg/day for 8 weeks
Measure Participants	22
Mean (Standard Deviation) [units on a scale]	18.67 (10.58)

Adverse Events

Arm/Group Title	Tolcapone
Arm/Group Description	Tolcapone 100-300mg/day Tolcapone : pill, 100-300mg/day for 8 weeks
All Cause Mortality
	Tolcapone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Tolcapone
	Affected / at Risk (%)	# Events
Total	0/24 (0%)
Other (Not Including Serious) Adverse Events
	Tolcapone
	Affected / at Risk (%)	# Events
Total	10/24 (41.7%)
Gastrointestinal disorders
Diarrhea	3/24 (12.5%)	3
Metabolism and nutrition disorders
Increased Appetite	1/24 (4.2%)	1
Psychiatric disorders
Vivid Dreams	2/24 (8.3%)	2
Broken Sleep	1/24 (4.2%)	1
Headache	1/24 (4.2%)	1
Skin and subcutaneous tissue disorders
Dry Mouth	2/24 (8.3%)	2

Limitations/Caveats

This study did not assess treatment effects beyond an 8-week treatment period and these results may not generalize to the larger population of people with PG.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.