Working… Menu

Drug Treatment for Pathologic Gambling Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00053677
Recruitment Status : Completed
First Posted : February 5, 2003
Results First Posted : October 3, 2017
Last Update Posted : October 3, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jon Grant, University of Chicago

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

Condition or disease Intervention/treatment Phase
Gambling Drug: Naltrexone Drug: Placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Naltrexone Treatment in Pathologic Gambling Disorder
Study Start Date : December 2002
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Naltrexone
17 weeks of double-blind Naltrexone. Subjects were randomized into one of these three conditions (if they weren't randomized to placebo): naltrexone 50mg/day, 100mg/day, 150mg/day. To minimize nausea, treatment for all subjects was initiated at 25mg/day naltrexone for two days, then the dose was increased to 50mg/day. At week 3, subjects were randomly assigned to 50mg/day continued at that dose, while subjects who were randomized to naltrexone 100mg/day or 150mg/day were raised to the higher doses.
Drug: Naltrexone
For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.

Placebo Comparator: Placebo
Subjects who were assigned to placebo in the 17 week double-blind phase.
Drug: Placebo
For subjects who were randomly assigned to placebo.

Primary Outcome Measures :
  1. Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS) [ Time Frame: 18 weeks ]
    A gambling severity measure derived from the Yale-Brown Obsessive Compulsive Scale. It sums gambling urges and thoughts questions to make a total score. Total scores range from 0 to 40, which higher scores indicating more severe gambling symptoms (worse outcome).Administered every week for the first 8 weeks and every other week for the remaining 10 weeks. Final visit scores were the scores measured at the last visit for each participant; data from previous visits were not combined to compute this value.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00053677

Layout table for location information
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)
Layout table for investigator information
Principal Investigator: Suck Won Kim, M.D. University of Minnesota - Clinical and Translational Science Institute

Layout table for additonal information
Responsible Party: Jon Grant, Professor, University of Chicago Identifier: NCT00053677     History of Changes
Other Study ID Numbers: R21MH065920 ( U.S. NIH Grant/Contract )
R21MH065920 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2003    Key Record Dates
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017
Last Verified: July 2017
Keywords provided by Jon Grant, University of Chicago:
Impulse Control Disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents