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NCT00132119 Clinical Trial

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

Pathological Gambling Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00132119
Other study ID # SP-N0406
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 17, 2005
Last updated May 15, 2008
Start date August 2005
Est. completion date August 2006

Study information
Verified date May 2008
Source Somaxon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 233
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• nalmefene HCl
Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.
Other:
• Placebo
Placebo tablet

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Somaxon Pharmaceuticals

Outcome
Type Measure Description Time frame Safety issue
Primary Assess efficacy in treatment of pathological gambling
Secondary Evaluate safety and tolerability in treatment of pathological gambling
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