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Drug Treatment for Pathologic Gambling Disorder - Article


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Naltrexone

ReVia



Clinical Trial: Drug Treatment for Pathologic Gambling Disorder

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to establish the best dose of the drug naltrexone for patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.

Condition Treatment or Intervention Phase
Impulse Control Disorders
 Drug: Naltrexone
Phase III

MedlinePlus related topics:  Mental Health

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: 

Expected Total Enrollment:  156

Study start: December 2002;  Expected completion: December 2005

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   -   75 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Location and Contact Information

Ann Wilson, B.A.      612-627-4879    wilso014@umn.edu

Minnesota
      University of Minnesota Medical School, Minneapolis,  Minnesota,  55454,  United States; Recruiting
Suck Won Kim, M.D.  612-273-9805    kimxx003@umn.edu 
Suck Won Kim, M.D.,  Principal Investigator

Study chairs or principal investigators

Suck Won Kim, M.D.,  Principal Investigator,  University of Minnesota   

More Information

Publications

Kim SW, Grant JE, Adson DE, Shin YC. Double-blind naltrexone and placebo comparison study in the treatment of pathological gambling. Biol Psychiatry. 2001 Jun 1;49(11):914-21.

Kim SW. Opioid antagonists in the treatment of impulse-control disorders. J Clin Psychiatry. 1998 Apr;59(4):159-64.

Kim SW, Grant JE. An open naltrexone treatment study in pathological gambling disorder. Int Clin Psychopharmacol. 2001 Sep;16(5):285-9.

Grant JE, Kim SW. Demographic and clinical features of 131 adult pathological gamblers. J Clin Psychiatry. 2001 Dec;62(12):957-62.

Kim SW, Grant JE. Personality dimensions in pathological gambling disorder and obsessive-compulsive disorder. Psychiatry Res. 2001 Nov 30;104(3):205-12.

Kim SW, Grant JE. The psychopharmacology of pathological gambling. Semin Clin Neuropsychiatry. 2001 Jul;6(3):184-94. Review.

Study ID Numbers:  65920-01
Record last reviewed:  November 2004
Last Updated:  November 9, 2004
Record first received:  February 4, 2003
ClinicalTrials.gov Identifier:  NCT00053677
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: June 1, 2005
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