Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

Emalex Biosciences

Status and phase: Completed; Phase 2

Conditions: Pathological Gambling

Treatments: Drug: Ecopipam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01215357

PSY201

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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34 participants in 2 patient groups, including a placebo group

Ecopipam

Experimental group

Description:

Ecopipam is a selective antagonist of one the classes of dopamine receptor.

Treatment:

Drug: Ecopipam

Placebo

Placebo Comparator group

Description:

Placebo given first week of the study.

Treatment:

Drug: Ecopipam