This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Drug Treatment for Pathologic Gambling Disorder

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by:
University of Chicago Identifier:
First received: February 4, 2003
Last updated: August 21, 2014
Last verified: August 2014
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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Naltrexone Treatment in Pathologic Gambling Disorder

Resource links provided by NLM:

Further study details as provided by University of Chicago:

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.


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00053677

United States, Minnesota
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Chicago
National Institute of Mental Health (NIMH)
Principal Investigator: Suck Won Kim, M.D. University of Minnesota - Clinical and Translational Science Institute