Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

Ecopipam Treatment of Pathological Gambling

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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Carver College of Medicine, University of Iowa
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ecopipam; Ecopipam is a selective antagonist of one the classes of dopamine receptor.	Drug: Ecopipam; 50mg tablets; Other Names: SCH 39166; PSYRX101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling	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.	Baseline and 6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Psyadon Pharma
• Investigators: Principal Investigator: Marc Potenza, MD, Yale University; Principal Investigator: Jon Grant, MD, Univ. of Minnesota; Principal Investigator: Donald Black, MD, Iowa University; Principal Investigator: Timothy Fong, MD, University of California, Los Angeles

Publications and helpful links

General Publications

• Grant JE, Odlaug BL, Black DW, Fong T, Davtian M, Chipkin R, Kim SW. A single-blind study of 'as-needed' ecopipam for gambling disorder. Ann Clin Psychiatry. 2014 Aug;26(3):179-86.

Helpful Links

• Psyadon Pharmaceutical's Website

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 4, 2010
• First Submitted That Met QC Criteria: October 5, 2010
• First Posted (Estimate): October 6, 2010

Study Record Updates

• Last Update Posted (Estimate): March 8, 2013
• Last Update Submitted That Met QC Criteria: February 28, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Dopamine; Pathological Gambling; ecopipam
• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Gambling; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Ecopipam
• Other Study ID Numbers: PSY201