Drug Treatment for Pathologic Gambling Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00053677
First received: February 4, 2003
Last updated: August 21, 2014
Last verified: August 2014

February 4, 2003
August 21, 2014
December 2002
November 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00053677 on ClinicalTrials.gov Archive Site
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Drug Treatment for Pathologic Gambling Disorder
Naltrexone Treatment in Pathologic Gambling Disorder

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Gambling
Drug: Naltrexone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
November 2005
November 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnostic and Statistical Manual 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
Both
21 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053677
R21 MH65920, R21MH065920, DSIR AT-AS
Not Provided
Not Provided
University of Chicago
National Institute of Mental Health (NIMH)
Principal Investigator: Suck Won Kim, M.D. University of Minnesota - Clinical and Translational Science Institute
University of Chicago
August 2014

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