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

Phase 2

Completed

• Conditions: Pathological Gambling
• Interventions: Other: Placebo; Drug: nalmefene HCl

• Registration Number: NCT00132119
• Lead Sponsor: Somaxon Pharmaceuticals

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-17
• Study First Submitted QC: 2005-08-17
• Study First Posted: 2005-08-19
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-15
• Last Update Posted: 2008-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	Placebo
1	nalmefene HCl	Nalmefene HCl 20 mg
2	nalmefene HCl	Nalmefene HCl 40 mg

Primary Outcome Measures

Name	Time	Method
Assess efficacy in treatment of pathological gambling

Secondary Outcome Measures

Name	Time	Method
Evaluate safety and tolerability in treatment of pathological gambling