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OpenTrials
Completed

NCT Number: NCT00053677

Drug Treatment for 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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Minnesota Medical School

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naltrexone

Drug

For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.

Placebo

Drug

For subjects who were randomly assigned to placebo.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Naltrexone Treatment in Pathologic Gambling Disorder

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Feb 5, 2003
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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