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Drug Treatment for Pathologic Gambling Disorder

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00053677
First received: February 4, 2003
Last updated: December 4, 2008
Last verified: August 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Naltrexone Treatment in Pathologic Gambling Disorder

Resource links provided by NLM:

U.S. FDA Resources

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
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Suck Won Kim, M.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

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

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

Additional relevant MeSH terms:
Gambling
Impulse Control Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013