Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with alcohol dependence.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Ethanol; Nalmefene; Naltrexone

Criteria

Inclusion Criteria:

In- and outpatients who:

• had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - text revision (DSM-IV-TR) criteria

• had had ≥6 Heavy Drinking Days (HDDs) in the 4 weeks preceding the Screening Visit

Exclusion Criteria:

The patient:

• had a severe psychiatric disorder or an antisocial personality disorder

• had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)

• had a history of delirium tremens or alcohol withdrawal seizures

• reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists

• was pregnant or breast-feeding

Other protocol-defined inclusion and exclusion criteria may apply.