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

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nalmefene HCl in the Treatment of Pathological Gambling

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00132119

Enrollment

233

Registered

2005-08-19

Start date

2005-08-31

Completion date

2006-08-31

Last updated

2008-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pathological Gambling

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.

Interventions

DRUGnalmefene HCl

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

OTHERPlacebo

Placebo tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Assess efficacy in treatment of pathological gambling	—

Secondary

Measure	Time frame
Evaluate safety and tolerability in treatment of pathological gambling	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026