Drug Treatment for Pathologic Gambling Disorder

University of Chicago83 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gambling

Interventions

NaltrexoneDRUG

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

PlaceboDRUG

For subjects who were randomly assigned to placebo.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota Medical School

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Yale-Brown Obsessive Compulsive Scale for Pathological Gambling (PG-YBOCS)

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.

Time frame: 18 weeks

Data from ClinicalTrials.gov

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