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

Somaxon Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pathological Gambling

Treatments: Drug: nalmefene HCl; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00132119

SP-N0406

Details and patient eligibility

About

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

Full 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.

Enrollment: 233 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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233 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Nalmefene HCl 20 mg

Treatment:

Drug: nalmefene HCl

2

Experimental group

Description:

Nalmefene HCl 40 mg

Treatment:

Drug: nalmefene HCl

3

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo