Clinical trial NCT01215357: Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble
Official title: Ecopipam Treatment of Pathological Gambling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pathological Gambling
Keywords: Pathological Gambling
ecopipam
Dopamine
Lead sponsor: Emalex Biosciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: Psyadon Pharma
First posted: 2010-10-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Type, Frequency and Severity of Side Effects
timeFrame: 6 weeks
measure: Statistically Significant Changes in the Gambling Symptom Assessment Scale
timeFrame: 6 weeks
measure: Effects on the Clinical Global Impression
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Iowa City
country: United States
facility: Carver College of Medicine, University of Iowa
state: Iowa
city: Minneapolis
country: United States
facility: University of Minnesota School of Medicine
state: Minnesota
Study officials:
affiliation: Univ. of Minnesota
name: Jon Grant, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iowa University
name: Donald Black, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Timothy Fong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Marc Potenza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.