Efficacy of Nalmefene in Patients With Alcohol Dependence (ESENSE1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00811720
First received: December 18, 2008
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Alcohol Dependence
Drug: Placebo
Drug: Nalmefene
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).


Secondary Outcome Measures:
  • Drinking Risk Level (RSDRL) Response [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    GGT values

  • Liver Function Test Alanine Aminotransferase (ALAT) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    ALAT values


Enrollment: 598
Study Start Date: December 2008
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
as-needed use, tablets, orally, 6 months
Experimental: Nalmefene Drug: Nalmefene
18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
Other Name: Selincro™

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811720

Locations
Austria
AT001
Linz, Austria, 4020
AT004
Salzburg, Austria, 5020
AT002
Vienna, Austria, 1230
AT003
Wien, Austria, 1090
Finland
FI009
Helsinki, Finland, 800
FI008
Helsinki, Finland, 560
FI007
Järvenpää, Finland, 4480
FI013
Kuopio, Finland, 70100
FI004
Kuusankoski, Finland, 45700
FI001
Mikkeli, Finland, 50100
FI015
Oulu, Finland, 90100
FI003
Tampere, Finland, 33100
FI002
Tampere, Finland, 339000
FI014
Turku, Finland, 20100
FI011
Vantaa, Finland, 1600
Germany
DE011
Bad Saarow, Germany, 15526
DE002
Berlin, Germany, 10629
DE005
Berlin, Germany, 10365
DE008
Berlin, Germany, 13156
DE016
Berlin, Germany, 10245
DE017
Berlin, Germany, 12524
DE019
Berlin, Germany, 13187
DE003
Essen, Germany, NW 45136
DE001
Hamburg, Germany, 22143
DE006
Hamburg, Germany, 20246
DE007
Leukersdorf, Germany, 09387
DE003
Mannheim, Germany, BW68159
DE014
Munich, Germany, 80336
DE010
Regensburg, Germany, BY 93053
DE018
Siegen, Germany, 57072
DE020
Wallerfing, Germany, 94574
Sweden
SE011
Gothenburg, Sweden, 402 76
SE005
Kalmar, Sweden, 391 85
SE006
Linköping, Sweden, 857 58
SE001
Malmo, Sweden, 211 22
SE002
Stockholm, Sweden, 141 86
SE004
Stockholm, Sweden, 118 91
SE008
Stockholm, Sweden, 17176
SE009
Uppsala, Sweden, 756 43
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00811720     History of Changes
Other Study ID Numbers: 12014A, 2007-002334-11
Study First Received: December 18, 2008
Results First Received: March 12, 2013
Last Updated: July 5, 2013
Health Authority: Austria: Agency for Health and Food Safety
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency

Keywords provided by H. Lundbeck A/S:
Alcohol-Related Disorders
Alcoholism
Mental Disorders
Central Nervous System Agents

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Agents
Nalmefene
Therapeutic Uses
Pharmacologic Actions
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014