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Drug Treatment for Pathologic Gambling Disorder

This study has been completed.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00053677
  Purpose

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


Condition Intervention Phase
Gambling
Drug: Naltrexone
Phase III

MedlinePlus related topics:   Compulsive Gambling   

ChemIDplus related topics:   Naltrexone    Naltrexone hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Naltrexone Treatment in Pathologic Gambling Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:   156
Study Start Date:   December 2002
Study Completion Date:   November 2005
Primary Completion Date:   November 2005 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053677

Locations
United States, Minnesota
University of Minnesota Medical School    
      Minneapolis, Minnesota, United States, 55454

Sponsors and Collaborators

Investigators
Principal Investigator:     Suck Won Kim, M.D.     University of Minnesota    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   R21 MH65920, DSIR AT-AS
First Received:   February 4, 2003
Last Updated:   August 22, 2008
ClinicalTrials.gov Identifier:   NCT00053677
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Institute of Mental Health (NIMH):
Impulse Control Disorders  

Study placed in the following topic categories:
Impulse Control Disorders
Gambling
Mental Disorders
Naltrexone

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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