Back to resultsNalmefene Gambling Study: Study of Nalmefene HCl in the Treatment of Pathological Gambling
Primary Purpose
Pathological Gambling
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
nalmefene HCl
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pathological Gambling
Eligibility Criteria
Inclusion Criteria: Current diagnosis of pathological gambling as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Nalmefene HCl 20 mg
Nalmefene HCl 40 mg
Placebo
Outcomes
Primary Outcome Measures
Assess efficacy in treatment of pathological gambling
Secondary Outcome Measures
Evaluate safety and tolerability in treatment of pathological gambling
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00132119
Brief Title
Nalmefene Gambling Study: Study of Nalmefene HCl in the Treatment of Pathological Gambling
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Somaxon Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nalmefene HCl 20 mg
Arm Title
2
Arm Type
Experimental
Arm Description
Nalmefene HCl 40 mg
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
nalmefene HCl
Intervention Description
Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Assess efficacy in treatment of pathological gambling
Secondary Outcome Measure Information:
Title
Evaluate safety and tolerability in treatment of pathological gambling
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current diagnosis of pathological gambling as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Jochelson, MD
Organizational Affiliation
Somaxon Pharmaceuticals CMO
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Nalmefene Gambling Study: Study of Nalmefene HCl in the Treatment of Pathological Gambling
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