Tolcapone Treatment of Pathological Gambling
1 other identifier
interventional
24
1 country
1
Brief Summary
The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in pathological gambling.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
March 6, 2014
CompletedFebruary 23, 2023
February 1, 2023
2.9 years
June 12, 2009
September 11, 2013
February 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)
Visit 5 (final visit)
Gambling Symptom Assessment Scale (G-SAS)
Visit 5 (final visit)
Study Arms (1)
Tolcapone
EXPERIMENTALTolcapone 100-300mg/day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ambulatory Research Center
Minneapolis, Minnesota, 55454, United States
Related Publications (1)
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.
PMID: 23953269DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and 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.
Results Point of Contact
- Title
- Dr. Jon Grant
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Jon E Grant, MD, JD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 25, 2009
Study Start
June 1, 2009
Primary Completion
May 1, 2012
Study Completion
July 1, 2012
Last Updated
February 23, 2023
Results First Posted
March 6, 2014
Record last verified: 2023-02