Nalmefene Gambling Study: Study of Nalmefene HCl in the Treatment of Pathological Gambling - Full Text View

Sponsored by:	Somaxon Pharmaceuticals
Information provided by:	Somaxon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00132119

Purpose

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

Condition	Intervention	Phase
Pathological Gambling	Drug: nalmefene HCl Other: Placebo	Phase II Phase III

MedlinePlus related topics: Compulsive Gambling

Drug Information available for: Nalmefene Nalmefene hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Somaxon Pharmaceuticals:

Primary Outcome Measures:

Assess efficacy in treatment of pathological gambling

Secondary Outcome Measures:

Evaluate safety and tolerability in treatment of pathological gambling

Enrollment:	233
Study Start Date:	August 2005
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Nalmefene HCl 20 mg	Drug: nalmefene HCl Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.
2: Experimental Nalmefene HCl 40 mg	Drug: nalmefene HCl Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.
3: Placebo Comparator Placebo	Other: Placebo Placebo tablet

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132119

Sponsors and Collaborators

Somaxon Pharmaceuticals

Investigators

Study Director:

Philip Jochelson, MD

Somaxon Pharmaceuticals CMO

More Information

No publications provided

Responsible Party:	Somaxon Pharmaceuticals
Study ID Numbers:	SP-N0406
Study First Received:	August 17, 2005
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00132119 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Impulse Control Disorders
Gambling
Mental Disorders
Narcotic Antagonists

Naltrexone
Narcotics
Peripheral Nervous System Agents
Nalmefene

Additional relevant MeSH terms:

Impulse Control Disorders
Gambling
Sensory System Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs

Narcotic Antagonists
Naltrexone
Peripheral Nervous System Agents
Central Nervous System Agents
Nalmefene
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009