Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01215357
Other study ID # PSY201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2010
Est. completion date August 2012

Study information

Verified date February 2013
Source Emalex Biosciences Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Other known NCT identifiers
  • NCT01198951

Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ecopipam
50mg tablets

Locations

Country Name City State
United States Carver College of Medicine, University of Iowa Iowa City Iowa
United States University of California, Los Angeles Los Angeles California
United States University of Minnesota School of Medicine Minneapolis Minnesota
United States Yale University New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Emalex Biosciences Inc. Psyadon Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Type, Frequency and Severity of Side Effects All side effects of the drug will be monitored and recorded 6 weeks
Secondary Statistically Significant Changes in the Gambling Symptom Assessment Scale It is expected that there will be decreases in this scale 6 weeks
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT02590211 - Poker, Skills and Associated Problems N/A
Completed NCT02203786 - D1 and D2 Dopamine Receptors in Gambling and Amphetamine Reinforcement Phase 2
Completed NCT05051085 - Feasibility of the Internet-delivered Treatment "SpilleFri" for Patients With Pathological Gambling N/A
Terminated NCT00245583 - Topiramate in the Treatment of Pathological Gambling Phase 3
Completed NCT04842461 - Mental Health, Addictions and Biomarkers in High Athletes Performance
Not yet recruiting NCT03280966 - Effects of Intranasal Naloxone on Gambling Urges in Gambling Disorder Phase 2
Active, not recruiting NCT01743092 - Testing Resources: Manual and Webinar Guided Treatment vs. Manual Guided Treatment N/A
Active, not recruiting NCT01528982 - Susceptibility to Pathological Gambling N/A
Terminated NCT00211822 - Functional Magnetic Resonance Imaging (fMRI) Studies in Pathological Gambling (PG) and Obsessive-Compulsive Disorder (OCD) N/A
Completed NCT01381250 - Effects of Internet-based Treatment of Pathological Gambling N/A
Completed NCT05506384 - Treatment Study for Problematic Gaming and Gambling N/A
Enrolling by invitation NCT03464838 - Effects of Transcranial Direct Current Stimulation (tDCS) in Gambling Disorder N/A
Terminated NCT01560351 - Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study N/A
Completed NCT00580567 - Impulsivity in Pathological Gambling N/A
Completed NCT02240485 - Integrative Couple Treatment for Pathological Gambling N/A
Withdrawn NCT01340274 - Community Reinforcement Approach and Family Training (CRAFT) for Problem Gambling Phase 2
Recruiting NCT02491996 - The Efficacy of Therapy Focused on Desire-satisfaction for Disordered Gamblers N/A
Recruiting NCT01154712 - Deep Low-Frequency Repetitive Transcranial Magnetic Stimulation for Cessation of Pathological Gambling Phase 1
Completed NCT00927563 - Tolcapone Treatment of Pathological Gambling Phase 2
Completed NCT01843699 - Topiramate Trial for Pathological Gamblers Phase 2