Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

Phase 2

Completed

Brief Summary: This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with Pathological Gambling.

Detailed Description: The purpose of this study is to determine if ecopipam is able to stop urges to gamble in patients diagnosed with Pathological Gambling. Nerves communicate with each other by releasing chemicals called "neurotransmitters". One of these neurotransmitters in the brain is called "dopamine". After dopamine is released by the nerve it "talks" to other nerves by interacting with receptors that are unique to that neurotransmitter. Ecopipam is a drug that selectively blocks one family of dopamine receptors. Some scientists believe that the urge to gamble is related to having too much dopamine in the brain. By blocking the receptors that dopamine uses, ecopipam may be able to relieve the urge to gamble.

Recruitment & Eligibility

Inclusion Criteria

Subject must be diagnosed with Pathological Gambling according to DSMIV criteria
Subject must have at least 2 episodes of gambling behavior within the previous 2 weeks before screening
Subject must have gambling urges of at least moderate intensity

Exclusion Criteria

Subjects must not have unstable medical illness or clinically significant abnormalities on lab tests, ECG, or physical exam
Subjects with major depressive episode within the last 2 years
Subjects with a history of attempted suicide
Subjects with first degree relative with major depressive episode that resulted in hospitalization, attempted or completed suicide
Subjects with a history of epilepsy or seizures
Subjects with a myocardial infarction (heart attack) with in the last 6 months
Subjects with a lifetime history of bipolar disorder, dementia, schizophrenia, or any psychotic disorder
Subjects with current of recent DSM-IV diagnosis of substance abuse or dependence (with the exception of nicotine)

Arm && Interventions

Group	Intervention	Description
Ecopipam	Ecopipam	Ecopipam is a selective antagonist of one the classes of dopamine receptor.
Placebo	Ecopipam	Placebo given first week of the study.

Primary Outcome Measures

Name	Time	Method
Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling	Baseline and 6 weeks	This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.

Secondary Outcome Measures

Name	Time	Method
Statistically Significant Changes in the Gambling Symptom Assessment Scale	6 weeks	It is expected that there will be decreases in this scale
Effects on the Clinical Global Impression	6 weeks	Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study
Type, Frequency and Severity of Side Effects	6 weeks	All side effects of the drug will be monitored and recorded

Locations (4): University of Minnesota School of Medicine
🇺🇸
Minneapolis, Minnesota, United States
Carver College of Medicine, University of Iowa
🇺🇸
Iowa City, Iowa, United States
Yale University
🇺🇸
New Haven, Connecticut, United States
University of California, Los Angeles
🇺🇸
Los Angeles, California, United States