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Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

NCT ID: NCT00811941

Last Updated: 2013-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

665 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-11-30

Brief Summary

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

Detailed Description

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Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the long-term safety and tolerability as well as to evaluate the efficacy of as needed use of 18.06 mg nalmefene in patients with alcohol dependence.

Conditions

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Alcohol Dependence

Keywords

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Pharmacologic Actions Alcohol-Related Disorders Alcoholism Mental Disorders Central Nervous System Agents

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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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

as-needed use, tablets, orally, 52 weeks

Nalmefene

Group Type EXPERIMENTAL

Nalmefene

Intervention Type DRUG

18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Interventions

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Placebo

as-needed use, tablets, orally, 52 weeks

Intervention Type DRUG

Nalmefene

18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Intervention Type DRUG

Other Intervention Names

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Selincro™

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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CZ007

Litoměřice, , Czechia

Site Status

CZ006

Lnáře, , Czechia

Site Status

CZ005

Prague, , Czechia

Site Status

CZ004

Prague, , Czechia

Site Status

CZ001

Ústí nad Labem, , Czechia

Site Status

EE002

Pärnu, , Estonia

Site Status

EE004

Tallinn, , Estonia

Site Status

EE005

Tallinn, , Estonia

Site Status

EE003

Vorumaa, , Estonia

Site Status

EE001

Võru, , Estonia

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HU004

Budapest, , Hungary

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HU002

Budapest, , Hungary

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LV003

Daugavpils, , Latvia

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LV002

Jelgava, , Latvia

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LV001

Riga, , Latvia

Site Status

LV004

Sigulda, , Latvia

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LT002

Kaunas, , Lithuania

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LT003

Kaunas, , Lithuania

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PL015

Bełchatów, , Poland

Site Status

PL008

Bydgoszcz, , Poland

Site Status

PL006

Gdansk, , Poland

Site Status

PL011

Krakow, , Poland

Site Status

PL002

Leszno, , Poland

Site Status

PL010

Lodz, , Poland

Site Status

PL014

Lodz, , Poland

Site Status

PL004

Lublin, , Poland

Site Status

PL005

Lublin, , Poland

Site Status

PL013

Piekary Śląskie, , Poland

Site Status

PL003

Skorzewo, , Poland

Site Status

PL007

Starogard Gdański, , Poland

Site Status

PL012

Swicie n/Wisla, , Poland

Site Status

PL009

Szczecin, , Poland

Site Status

PL001

Torun, , Poland

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RU013

Rostov-on-Don, , Russia

Site Status

RU002

Saint Petersburg, , Russia

Site Status

RU005

Saint Petersburg, , Russia

Site Status

RU006

Saint Petersburg, , Russia

Site Status

RU001

Saint Petersburg, , Russia

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RU012

Saint Petersburg, , Russia

Site Status

RU003

Saint Petersburg, , Russia

Site Status

RU004

Voronezh, , Russia

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SK001

Banska Bysterica, , Slovakia

Site Status

SK002

Krupina, , Slovakia

Site Status

SK004

Nitra, , Slovakia

Site Status

SK005

Rimavská Sobota, , Slovakia

Site Status

UA001

Chernihiv, , Ukraine

Site Status

UA008

Dnipropetrovsk, , Ukraine

Site Status

UA003

Donetsk, , Ukraine

Site Status

UA004

Hlevakha, , Ukraine

Site Status

UA007

Kharkiv, , Ukraine

Site Status

UA009

Kherson, , Ukraine

Site Status

UA002

Kyiv, , Ukraine

Site Status

UA005

Odesa, , Ukraine

Site Status

UA006

Simferopol, , Ukraine

Site Status

UA010

Ternopil, , Ukraine

Site Status

GB007

Birmingham, , United Kingdom

Site Status

GB006

Glasgow, , United Kingdom

Site Status

GB009

London, , United Kingdom

Site Status

GB008

Manchester, , United Kingdom

Site Status

GB005

Reading, , United Kingdom

Site Status

Countries

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Czechia Estonia Hungary Latvia Lithuania Poland Russia Slovakia Ukraine United Kingdom

References

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Laramee P, Brodtkorb TH, Rahhali N, Knight C, Barbosa C, Francois C, Toumi M, Daeppen JB, Rehm J. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model. BMJ Open. 2014 Sep 16;4(9):e005376. doi: 10.1136/bmjopen-2014-005376.

Reference Type DERIVED
PMID: 25227627 (View on PubMed)

Other Identifiers

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2007-002315-92

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12013A

Identifier Type: -

Identifier Source: org_study_id