Nalmefene Gambling Study: Study of Nalmefene HCl in the Treatment of Pathological Gambling

Somaxon Pharmaceuticals233 enrolled

Overview

The purpose of this study is to determine if nalmefene is safe and effective in the treatment of pathological gambling.

Randomized, double-blind, placebo-controlled, parallel-group, multi-centered, outpatient study to assess the efficacy, safety and tolerability of two doses of nalmefene in patients with current diagnosis of pathological gambling.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

233

Conditions

Pathological Gambling

Interventions

nalmefene HClDRUG

Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.

PlaceboOTHER

Placebo tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Current diagnosis of pathological gambling as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)

Outcomes

Primary Outcomes

Assess efficacy in treatment of pathological gambling

Secondary Outcomes

Evaluate safety and tolerability in treatment of pathological gambling

Data from ClinicalTrials.gov

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