NCT00053677

Drug Treatment for Pathologic Gambling Disorder

Naltrexone Treatment in Pathologic Gambling Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Gambling

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-12-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2003-02-05
• Last updated: 2023-02-23
• Results posted: 2017-10-03

Locations

1 site across 1 country: United States