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

NCT ID: NCT00132119

Last Updated: 2008-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pathological Gambling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Nalmefene HCl 20 mg

Group Type EXPERIMENTAL

nalmefene HCl

Intervention Type DRUG

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

2

Nalmefene HCl 40 mg

Group Type EXPERIMENTAL

nalmefene HCl

Intervention Type DRUG

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

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablet

Interventions

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nalmefene HCl

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

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Somaxon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Somaxon Pharmaceuticals

Principal Investigators

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Philip Jochelson, MD

Role: STUDY_DIRECTOR

Somaxon Pharmaceuticals CMO

Countries

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United States

Other Identifiers

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SP-N0406

Identifier Type: -

Identifier Source: org_study_id