Clinical trial NCT00811941: Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence
Official title: A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Safety, Tolerability and Efficacy Study of 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: 2008-12-19
Enrollment: 665
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 long-term safety, tolerability and efficacy of nalmefene in patients with 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 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.

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 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.

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs)
timeFrame: Serious Adverse Events: 52 weeks and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 52 weeks.
measure: Percentage of Patients Who Withdrew Due to Intolerance to Treatment
timeFrame: Baseline to Week 52
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
measure: Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)
timeFrame: Baseline and Month 13
measure: Change From Baseline in the Monthly Total Alcohol Consumption (TAC)
timeFrame: Baseline and Month 13
measure: Drinking Risk Level (RSDRL) Response
timeFrame: Month 13
measure: Change From Baseline in Clinical Status Using CGI-S
timeFrame: Baseline and Week 52
measure: Change in Clinical Status Using the CGI-I
timeFrame: Week 52
measure: Liver Function Test Gamma-glutamyl Transferase (GGT)
timeFrame: Week 52
measure: Liver Function Test Alanine Aminotransferase (ALAT)
timeFrame: Week 52
Other outcomes:
Locations:
city: Litomerice
country: Czech Republic
facility: CZ007
city: Lnare
country: Czech Republic
facility: CZ006
city: Prague
country: Czech Republic
facility: CZ005
city: Praha 6
country: Czech Republic
facility: CZ004
city: Usti nad Labem
country: Czech Republic
facility: CZ001
city: Parnu
country: Estonia
facility: EE002
city: Tallinn
country: Estonia
facility: EE004
city: Tallinn
country: Estonia
facility: EE005
city: Vorumaa
country: Estonia
facility: EE003
city: Voru
country: Estonia
facility: EE001
city: Budapest
country: Hungary
facility: HU004
city: Budapest
country: Hungary
facility: HU002
city: Daugavpils
country: Latvia
facility: LV003
city: Jelgava
country: Latvia
facility: LV002
city: Riga
country: Latvia
facility: LV001
city: Sigulda
country: Latvia
facility: LV004
city: Kaunas
country: Lithuania
facility: LT002
city: Kaunas
country: Lithuania
facility: LT003
city: Belchatow
country: Poland
facility: PL015
city: Bydgoszcz
country: Poland
facility: PL008
city: Gdansk
country: Poland
facility: PL006
city: Krakow
country: Poland
facility: PL011
city: Leszno
country: Poland
facility: PL002
city: Lodz
country: Poland
facility: PL010
city: Lodz
country: Poland
facility: PL014
city: Lublin
country: Poland
facility: PL004
city: Lublin
country: Poland
facility: PL005
city: Piekary Slaskie
country: Poland
facility: PL013
city: Skorzewo
country: Poland
facility: PL003
city: Starogard Gdanski
country: Poland
facility: PL007
city: Swicie n/Wisla
country: Poland
facility: PL012
city: Szczecin
country: Poland
facility: PL009
city: Torun
country: Poland
facility: PL001
city: Leningrad
country: Russian Federation
facility: RU002
city: Rostov on Don
country: Russian Federation
facility: RU013
city: St. Petersburg
country: Russian Federation
facility: RU005
city: St. Petersburg
country: Russian Federation
facility: RU006
city: St. Petersburg
country: Russian Federation
facility: RU001
city: St. Petersburg
country: Russian Federation
facility: RU012
city: St. Petersburg
country: Russian Federation
facility: RU003
city: Voronezh
country: Russian Federation
facility: RU004
city: Banska Bysterica
country: Slovakia
facility: SK001
city: Krupina
country: Slovakia
facility: SK002
city: Nitra
country: Slovakia
facility: SK004
city: Rimavska Sobota
country: Slovakia
facility: SK005
city: Chernihiv
country: Ukraine
facility: UA001
city: Dnipropetrovsk
country: Ukraine
facility: UA008
city: Donetsk
country: Ukraine
facility: UA003
city: Glevakha
country: Ukraine
facility: UA004
city: Kharkiv
country: Ukraine
facility: UA007
city: Kherson
country: Ukraine
facility: UA009
city: Kyiv
country: Ukraine
facility: UA002
city: Odessa
country: Ukraine
facility: UA005
city: Simferopol
country: Ukraine
facility: UA006
city: Ternopil
country: Ukraine
facility: UA010
city: Birmingham
country: United Kingdom
facility: GB007
city: Glasgow
country: United Kingdom
facility: GB006
city: London
country: United Kingdom
facility: GB009
city: Manchester
country: United Kingdom
facility: GB008
city: Reading
country: United Kingdom
facility: GB005
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
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.