Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

NCT ID: NCT01215357

Last Updated: 2024-05-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Pathological Gambling

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ecopipam

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

Group Type EXPERIMENTAL

Ecopipam

Intervention Type DRUG

50mg tablets

Placebo

Placebo given first week of the study.

Group Type PLACEBO_COMPARATOR

Ecopipam

Intervention Type DRUG

50mg tablets

Interventions

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Ecopipam

50mg tablets

Intervention Type DRUG

Other Intervention Names

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PSYRX101 SCH 39166

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Psyadon Pharma

INDUSTRY

Sponsor Role collaborator

Emalex Biosciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jon Grant, MD

Role: PRINCIPAL_INVESTIGATOR

Univ. of Minnesota

Donald Black, MD

Role: PRINCIPAL_INVESTIGATOR

Iowa University

Timothy Fong, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Marc Potenza, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Carver College of Medicine, University of Iowa

Iowa City, Iowa, United States

Site Status

University of Minnesota School of Medicine

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25166480 (View on PubMed)

Related Links

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http://www.psyadonrx.com

Psyadon Pharmaceutical's Website

Other Identifiers

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PSY201

Identifier Type: -

Identifier Source: org_study_id

NCT01198951

Identifier Type: -

Identifier Source: nct_alias

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