Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence
- Registration Number
- NCT00811941
- Lead Sponsor
- H. Lundbeck A/S
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 665
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Nalmefene Nalmefene -
- Primary Outcome Measures
Name Time Method Number of Patients With Adverse Events (AEs) 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. Overview of AEs
Percentage of Patients Who Withdrew Due to Intolerance to Treatment Baseline to Week 52 Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) Baseline and Month 6 Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.
Change From Baseline in the Monthly Total Alcohol Consumption (TAC) Baseline and Month 6 TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
- Secondary Outcome Measures
Name Time Method Drinking Risk Level (RSDRL) Response Month 13 RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.
Change From Baseline in Clinical Status Using CGI-S Baseline and Week 52 The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
Change in Clinical Status Using the CGI-I Week 52 The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).
Liver Function Test Gamma-glutamyl Transferase (GGT) Week 52 GGT values
Liver Function Test Alanine Aminotransferase (ALAT) Week 52 ALAT values
Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) Baseline and Month 13 Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 g for men and ≥40 g for women.
Change From Baseline in the Monthly Total Alcohol Consumption (TAC) Baseline and Month 13 TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
Trial Locations
- Locations (60)
UA010
🇺🇦Ternopil, Ukraine
CZ001
🇨🇿Usti nad Labem, Czech Republic
PL011
🇵🇱Krakow, Poland
RU006
🇷🇺St. Petersburg, Russian Federation
SK004
🇸🇰Nitra, Slovakia
UA009
🇺🇦Kherson, Ukraine
RU013
🇷🇺Rostov on Don, Russian Federation
UA007
🇺🇦Kharkiv, Ukraine
PL015
🇵🇱Belchatow, Poland
PL010
🇵🇱Lodz, Poland
PL012
🇵🇱Swicie n/Wisla, Poland
UA003
🇺🇦Donetsk, Ukraine
LV004
🇱🇻Sigulda, Latvia
PL008
🇵🇱Bydgoszcz, Poland
PL002
🇵🇱Leszno, Poland
PL003
🇵🇱Skorzewo, Poland
UA006
🇺🇦Simferopol, Ukraine
LT003
🇱🇹Kaunas, Lithuania
PL006
🇵🇱Gdansk, Poland
PL014
🇵🇱Lodz, Poland
PL007
🇵🇱Starogard Gdanski, Poland
RU002
🇷🇺Leningrad, Russian Federation
RU005
🇷🇺St. Petersburg, Russian Federation
SK001
🇸🇰Banska Bysterica, Slovakia
UA004
🇺🇦Glevakha, Ukraine
CZ007
🇨🇿Litomerice, Czech Republic
CZ004
🇨🇿Praha 6, Czech Republic
EE002
🇪🇪Parnu, Estonia
EE004
🇪🇪Tallinn, Estonia
EE001
🇪🇪Voru, Estonia
LV002
🇱🇻Jelgava, Latvia
LV001
🇱🇻Riga, Latvia
LT002
🇱🇹Kaunas, Lithuania
PL009
🇵🇱Szczecin, Poland
PL001
🇵🇱Torun, Poland
HU002
🇭🇺Budapest, Hungary
CZ006
🇨🇿Lnare, Czech Republic
CZ005
🇨🇿Prague, Czech Republic
EE005
🇪🇪Tallinn, Estonia
EE003
🇪🇪Vorumaa, Estonia
HU004
🇭🇺Budapest, Hungary
PL004
🇵🇱Lublin, Poland
PL005
🇵🇱Lublin, Poland
PL013
🇵🇱Piekary Slaskie, Poland
RU001
🇷🇺St. Petersburg, Russian Federation
RU004
🇷🇺Voronezh, Russian Federation
RU012
🇷🇺St. Petersburg, Russian Federation
RU003
🇷🇺St. Petersburg, Russian Federation
SK002
🇸🇰Krupina, Slovakia
SK005
🇸🇰Rimavska Sobota, Slovakia
UA001
🇺🇦Chernihiv, Ukraine
UA008
🇺🇦Dnipropetrovsk, Ukraine
GB007
🇬🇧Birmingham, United Kingdom
GB006
🇬🇧Glasgow, United Kingdom
GB009
🇬🇧London, United Kingdom
UA002
🇺🇦Kyiv, Ukraine
UA005
🇺🇦Odessa, Ukraine
GB008
🇬🇧Manchester, United Kingdom
LV003
🇱🇻Daugavpils, Latvia
GB005
🇬🇧Reading, United Kingdom