Drug Treatment for Pathologic Gambling Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

February 4, 2003

Last Updated Date

December 4, 2008

Start Date ^ICMJE

December 2002

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00053677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Drug Treatment for Pathologic Gambling Disorder

Official Title ^ICMJE

Naltrexone Treatment in Pathologic Gambling Disorder

Brief Summary

This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.

Detailed Description

PGD is a prominent and growing social problem. Unfortunately, there is no established drug treatment for this disorder. Preliminary investigations demonstrate that naltrexone in doses up to 250 mg/day is well tolerated and safe during an 11-week period and may be a viable treatment option for PGD patients with severe urges. The implications of this study extend from PGD to other impulse control disorders, including compulsive shopping, kleptomania, and possibly alcoholism.

Participants are randomly assigned to receive either naltrexone or placebo for 16 weeks. The responses of men and women are compared to determine whether efficacy is distributed in a male:female ratio analogous to that of the PGD population in the United States. A Clinical Global Impression and a Gambling Symptom Scale are used to assess participants.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Gambling

Intervention ^ICMJE

Drug: Naltrexone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

156

Completion Date

November 2005

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

DSM-IV criteria for Pathological Gambling Disorder
Moderate or severe gambling urge assessed by the Gambling Symptom Assessment Scale
No psychiatric drug use for 2 weeks or more
Score >= 5 on The South Oaks Gambling Screen
Hamilton Depression Rating Scale and Anxiety Rating score < 26. An increase (up to 10 points) of the scores is allowed unless the subject shows the risks of suicide.
Completion of complete blood count, urinalysis, liver and thyroid function tests, and pregnancy tests, with no evidence of significant lab abnormalities
Reliable birth control in women of child-bearing potential

Gender

Both

Ages

21 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00053677

Responsible Party

Study ID Numbers ^ICMJE

R21 MH65920, DSIR AT-AS

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Suck Won Kim, M.D.

University of Minnesota

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP