Efficacy of Nalmefene in Patients With Alcohol Dependence
- Registration Number
- NCT00812461
- Lead Sponsor
- H. Lundbeck A/S
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 678
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Nalmefene Nalmefene -
- Primary Outcome Measures
Name Time Method 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 Change From Baseline in Clinical Status Using CGI-S Baseline and Week 24 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).
Drinking Risk Level (RSDRL) Response Month 6 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 in Clinical Status Using the CGI-I Week 24 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 24 GGT values
Liver Function Test Alanine Aminotransferase (ALAT) Week 24 ALAT values
Trial Locations
- Locations (57)
FR009
🇫🇷Clichy Cedex 92, France
ES004
🇪🇸Barcelona, Spain
ES002
🇪🇸Oviedo, Spain
PL005
🇵🇱Gdansk, Poland
FR015
🇫🇷Nimes, France
IT013
🇮🇹Bologna, Italy
IT008
🇮🇹Cento, Italy
FR008
🇫🇷Angers, France
BE004
🇧🇪Oostende, Belgium
PL003
🇵🇱Skorzewo, Poland
BE007
🇧🇪Brugge, Belgium
BE006
🇧🇪Charleroi, Belgium
BE001
🇧🇪Liège, Belgium
CZ002
🇨🇿Praha 10, Czech Republic
BE002
🇧🇪Assebroek, Belgium
FR011
🇫🇷Le Pecq, France
FR001
🇫🇷Sartrouville, France
ES011
🇪🇸Zamora, Spain
ES006
🇪🇸Barcelona, Spain
BE003
🇧🇪Mechelen, Belgium
CZ003
🇨🇿Praha 6, Czech Republic
FR014
🇫🇷Nancy, France
FR016
🇫🇷Lyon, France
FR004
🇫🇷Bully les Mines, France
FR021
🇫🇷La Rochelle, France
FR012
🇫🇷Elancourt, France
FR019
🇫🇷Lille, France
IT001
🇮🇹Rome, Italy
FR002
🇫🇷Rennes, France
FR007
🇫🇷Strasbourg, France
FR005
🇫🇷Toulouse, France
IT017
🇮🇹Bologna, Italy
FR006
🇫🇷Toulouse, France
IT006
🇮🇹Firenze, Italy
FR003
🇫🇷Villejuif, France
IT007
🇮🇹Rome, Italy
IT011
🇮🇹Rome, Italy
IT004
🇮🇹Rome, Italy
IT002
🇮🇹Parma, Italy
PL006
🇵🇱Lublin, Poland
PL007
🇵🇱Lublin, Poland
PL004
🇵🇱Leszno, Poland
IT018
🇮🇹Soverato, Italy
PL002
🇵🇱Piekary Slaskie, Poland
PT003
🇵🇹Angra do Heroismo, Portugal
PT001
🇵🇹Lisboa, Portugal
PT002
🇵🇹Lisboa, Portugal
PT006
🇵🇹Mem Martins, Portugal
ES005
🇪🇸Alicante, Spain
ES008
🇪🇸Barcelona, Spain
ES010
🇪🇸Madrid, Spain
ES014
🇪🇸Burgos, Spain
ES003
🇪🇸Valencia, Spain
ES001
🇪🇸Mallorca, Spain
CZ001
🇨🇿Litomerice, Czech Republic
PL001
🇵🇱Szczecin, Poland
BE005
🇧🇪Kortenberg, Belgium