Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble
This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with Pathological Gambling.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Ecopipam Treatment of Pathological Gambling|
- Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]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.
- Type, Frequency and Severity of Side Effects [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]All side effects of the drug will be monitored and recorded
- Statistically Significant Changes in the Gambling Symptom Assessment Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]It is expected that there will be decreases in this scale
- Effects on the Clinical Global Impression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study
|Study Start Date:||October 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Ecopipam is a selective antagonist of one the classes of dopamine receptor.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215357
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06519|
|United States, Iowa|
|Carver College of Medicine, University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Minnesota|
|University of Minnesota School of Medicine|
|Minneapolis, Minnesota, United States, 55454|
|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|
|Principal Investigator:||Marc Potenza, MD||Yale University|