Clinical trial NCT00811720: Efficacy of Nalmefene in Patients With Alcohol Dependence
Official title: Nalmefene Efficacy Study I: 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: Alcohol-Related Disorders
Alcoholism
Mental Disorders
Central Nervous System Agents
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 598
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 6 months 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: Linz
country: Austria
facility: AT001
city: Salzburg
country: Austria
facility: AT004
city: Vienna
country: Austria
facility: AT002
city: Wien
country: Austria
facility: AT003
city: Helsinki
country: Finland
facility: FI008
city: Helsinki
country: Finland
facility: FI009
city: Järvenpää
country: Finland
facility: FI007
city: Kuopio
country: Finland
facility: FI013
city: Kuusankoski
country: Finland
facility: FI004
city: Mikkeli
country: Finland
facility: FI001
city: Oulu
country: Finland
facility: FI015
city: Tampere
country: Finland
facility: FI003
city: Tampere
country: Finland
facility: FI002
city: Turku
country: Finland
facility: FI014
city: Vantaa
country: Finland
facility: FI011
city: Bad Saarow
country: Germany
facility: DE011
city: Berlin
country: Germany
facility: DE016
city: Berlin
country: Germany
facility: DE005
city: Berlin
country: Germany
facility: DE002
city: Berlin
country: Germany
facility: DE017
city: Berlin
country: Germany
facility: DE008
city: Berlin
country: Germany
facility: DE019
city: Essen
country: Germany
facility: DE003
city: Hamburg
country: Germany
facility: DE006
city: Hamburg
country: Germany
facility: DE001
city: Leukersdorf
country: Germany
facility: DE007
city: Mannheim
country: Germany
facility: DE003
city: Munich
country: Germany
facility: DE014
city: Regensburg
country: Germany
facility: DE010
city: Siegen
country: Germany
facility: DE018
city: Wallerfing
country: Germany
facility: DE020
city: Gothenburg
country: Sweden
facility: SE011
city: Kalmar
country: Sweden
facility: SE005
city: Linköping
country: Sweden
facility: SE006
city: Malmo
country: Sweden
facility: SE001
city: Stockholm
country: Sweden
facility: SE004
city: Stockholm
country: Sweden
facility: SE002
city: Stockholm
country: Sweden
facility: SE008
city: Uppsala
country: Sweden
facility: SE009
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Mann K, Bladstrom A, Torup L, Gual A, van den Brink W. Extending the treatment options in alcohol dependence: a randomized controlled study of as-needed nalmefene. Biol Psychiatry. 2013 Apr 15;73(8):706-13. doi: 10.1016/j.biopsych.2012.10.020. Epub 2012 Dec 11.
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.