Drug Treatment for Pathologic Gambling Disorder - Full Text View

Sponsor:	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

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:

MedlinePlus related topics: Compulsive Gambling

Drug Information available for: Naltrexone Naltrexone hydrochloride

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:

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.

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 February 12, 2012