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

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ClinicalTrials.gov Identifier: NCT00132119
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : May 19, 2008
Sponsor:
Information provided by:
Somaxon Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Pathological Gambling Drug: nalmefene HCl Other: Placebo Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Nalmefene HCl 20 mg
Drug: nalmefene HCl
Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.

Experimental: 2
Nalmefene HCl 40 mg
Drug: nalmefene HCl
Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.

Placebo Comparator: 3
Placebo
Other: Placebo
Placebo tablet




Primary Outcome Measures :
  1. Assess efficacy in treatment of pathological gambling

Secondary Outcome Measures :
  1. Evaluate safety and tolerability in treatment of pathological gambling


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132119


Sponsors and Collaborators
Somaxon Pharmaceuticals
Investigators
Study Director: Philip Jochelson, MD Somaxon Pharmaceuticals CMO

Responsible Party: Somaxon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00132119     History of Changes
Other Study ID Numbers: SP-N0406
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: May 19, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Nalmefene
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents