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Completed

NCT Number: NCT00132119

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

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

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Key information

Conditions

Pathological Gambling Behavior Disruptive, Impulse Control, and Conduct Disorders Gambling Mental Disorders Risk-Taking

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

nalmefene HCl

Drug

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

Placebo

Other

Placebo tablet

Primary outcomes

  1. Assess efficacy in treatment of pathological gambling

Secondary outcomes

  1. Evaluate safety and tolerability in treatment of pathological gambling

Sponsors and collaborators

Lead sponsor

Somaxon Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nalmefene HCl in the Treatment of Pathological Gambling

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 19, 2005
Registry last updated
May 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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