Clinical trial NCT00812461: Efficacy of Nalmefene in Patients With Alcohol Dependence
Official title: Nalmefene Efficacy Study II: Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy Study of 20 mg Nalmefene, as Needed Use, in Patients With Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Keywords: Pharmacologic Actions
Alcohol-Related Disorders
Alcoholism
Mental Disorders
Central Nervous System Agents
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

Detailed description: 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 efficacy and safety of as needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 24 weeks in adult patients with alcohol dependence.

Eligibility 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 HDDs in the 4 weeks preceding the Screening Visit
* had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit

Exclusion Criteria:

The patient:

* had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence
* had 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
* reported current or recent treatment with antipsychotics or antidepressants
* was pregnant or breast-feeding

Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)
timeFrame: Baseline and Month 6
measure: Change From Baseline in the Monthly Total Alcohol Consumption (TAC)
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Drinking Risk Level (RSDRL) Response
timeFrame: Month 6
measure: Change From Baseline in Clinical Status Using CGI-S
timeFrame: Baseline and Week 24
measure: Change in Clinical Status Using the CGI-I
timeFrame: Week 24
measure: Liver Function Test Gamma-glutamyl Transferase (GGT)
timeFrame: Week 24
measure: Liver Function Test Alanine Aminotransferase (ALAT)
timeFrame: Week 24
Other outcomes:
Locations:
city: Assebroek
country: Belgium
facility: BE002
city: Brugge
country: Belgium
facility: BE007
city: Charleroi
country: Belgium
facility: BE006
city: Kortenberg
country: Belgium
facility: BE005
city: Liège
country: Belgium
facility: BE001
city: Mechelen
country: Belgium
facility: BE003
city: Oostende
country: Belgium
facility: BE004
city: Litomerice
country: Czech Republic
facility: CZ001
city: Praha 10
country: Czech Republic
facility: CZ002
city: Praha 6
country: Czech Republic
facility: CZ003
city: Angers
country: France
facility: FR008
city: Bully les Mines
country: France
facility: FR004
city: Clichy Cedex 92
country: France
facility: FR009
city: Elancourt
country: France
facility: FR012
city: La Rochelle
country: France
facility: FR021
city: Le Pecq
country: France
facility: FR011
city: Lille
country: France
facility: FR019
city: Lyon
country: France
facility: FR016
city: Nancy
country: France
facility: FR014
city: Nimes
country: France
facility: FR015
city: Rennes
country: France
facility: FR002
city: Sartrouville
country: France
facility: FR001
city: Strasbourg
country: France
facility: FR007
city: Toulouse
country: France
facility: FR005
city: Toulouse
country: France
facility: FR006
city: Villejuif
country: France
facility: FR003
city: Bologna
country: Italy
facility: IT017
city: Bologna
country: Italy
facility: IT013
city: Cento
country: Italy
facility: IT008
city: Firenze
country: Italy
facility: IT006
city: Parma
country: Italy
facility: IT002
city: Rome
country: Italy
facility: IT007
city: Rome
country: Italy
facility: IT001
city: Rome
country: Italy
facility: IT011
city: Rome
country: Italy
facility: IT004
city: Soverato
country: Italy
facility: IT018
city: Gdansk
country: Poland
facility: PL005
city: Leszno
country: Poland
facility: PL004
city: Lublin
country: Poland
facility: PL006
city: Lublin
country: Poland
facility: PL007
city: Piekary Slaskie
country: Poland
facility: PL002
city: Skorzewo
country: Poland
facility: PL003
city: Szczecin
country: Poland
facility: PL001
city: Angra do Heroismo
country: Portugal
facility: PT003
city: Lisboa
country: Portugal
facility: PT002
city: Lisboa
country: Portugal
facility: PT001
city: Mem Martins
country: Portugal
facility: PT006
city: Alicante
country: Spain
facility: ES005
city: Barcelona
country: Spain
facility: ES006
city: Barcelona
country: Spain
facility: ES008
city: Barcelona
country: Spain
facility: ES004
city: Burgos
country: Spain
facility: ES014
city: Madrid
country: Spain
facility: ES010
city: Mallorca
country: Spain
facility: ES001
city: Oviedo
country: Spain
facility: ES002
city: Valencia
country: Spain
facility: ES003
city: Zamora
country: Spain
facility: ES011
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Gual A, He Y, Torup L, van den Brink W, Mann K; ESENSE 2 Study Group. A randomised, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence. Eur Neuropsychopharmacol. 2013 Nov;23(11):1432-42. doi: 10.1016/j.euroneuro.2013.02.006. Epub 2013 Apr 3.
citation: Aubin HJ, Reimer J, Nutt DJ, Bladstrom A, Torup L, Francois C, Chick J. Clinical relevance of as-needed treatment with nalmefene in alcohol-dependent patients. Eur Addict Res. 2015;21(3):160-168. doi: 10.1159/000371547. Epub 2015 Mar 31.
citation: 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.
citation: van den Brink W, Aubin HJ, Bladstrom A, Torup L, Gual A, Mann K. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013 Sep-Oct;48(5):570-8. doi: 10.1093/alcalc/agt061. Epub 2013 Jul 19.