Clinical trial

Naltrexone Treatment in Pathologic Gambling Disorder

Name

R21MH065920

Description

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

Trial arms

Trial start

2002-12-01

Estimated PCD

2005-11-01

Trial end

2005-11-01

Status

Completed

Phase

Early phase I

Treatment

Naltrexone

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

Arms:

Naltrexone

Placebo

For subjects who were randomly assigned to placebo.

Arms:

Placebo

Size

Primary endpoint

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

18 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 83, 'type': 'ACTUAL'}}

Updated at

2023-02-23

1 organization

1 product

1 drug

1 indication

Organization

University of Chicago

Product

Naltrexone

Indication

pathological gambling

Drug

Varlilumab