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Drug Treatment for Pathologic Gambling Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00053677
First Posted: February 5, 2003
Last Update Posted: October 3, 2017
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jon Grant, University of Chicago
February 4, 2003
February 5, 2003
April 3, 2017
October 3, 2017
October 3, 2017
December 2002
November 2005   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00053677 on ClinicalTrials.gov Archive Site
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Drug Treatment for Pathologic Gambling Disorder
Naltrexone Treatment in Pathologic Gambling Disorder
This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gambling
  • Drug: Naltrexone
    For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.
  • Drug: Placebo
    For subjects who were randomly assigned to placebo.
  • 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.
    Intervention: Drug: Naltrexone
  • Placebo Comparator: Placebo
    Subjects who were assigned to placebo in the 17 week double-blind phase.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
November 2005
November 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00053677
R21MH065920( U.S. NIH Grant/Contract )
R21MH065920 ( U.S. NIH Grant/Contract )
DSIR AT-AS
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Jon Grant, University of Chicago
University of Chicago
National Institute of Mental Health (NIMH)
Principal Investigator: Suck Won Kim, M.D. University of Minnesota - Clinical and Translational Science Institute
University of Chicago
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP