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Efficacy of Nalmefene in Patients With Alcohol Dependence (ESENSE1)

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Nalmefene
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol-Related Disorders, Alcoholism, Mental Disorders, Central Nervous System Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AT001
  • AT004
  • AT002
  • AT003
  • FI008
  • FI009
  • FI007
  • FI013
  • FI004
  • FI001
  • FI015
  • FI003
  • FI002
  • FI014
  • FI011
  • DE011
  • DE016
  • DE005
  • DE002
  • DE017
  • DE008
  • DE019
  • DE003
  • DE006
  • DE001
  • DE007
  • DE003
  • DE014
  • DE010
  • DE018
  • DE020
  • SE011
  • SE005
  • SE006
  • SE001
  • SE004
  • SE002
  • SE008
  • SE009

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Nalmefene

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)
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)
TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).

Secondary Outcome Measures

Drinking Risk Level (RSDRL) Response
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
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
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)
GGT values
Liver Function Test Alanine Aminotransferase (ALAT)
ALAT values

Full Information

First Posted
December 18, 2008
Last Updated
July 5, 2013
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00811720
Brief Title
Efficacy of Nalmefene in Patients With Alcohol Dependence
Acronym
ESENSE1
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol-Related Disorders, Alcoholism, Mental Disorders, Central Nervous System Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
598 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Nalmefene
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
as-needed use, tablets, orally, 6 months
Intervention Type
Drug
Intervention Name(s)
Nalmefene
Other Intervention Name(s)
Selincro™
Intervention Description
18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
Primary Outcome Measure Information:
Title
Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)
Description
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.
Time Frame
Baseline and Month 6
Title
Change From Baseline in the Monthly Total Alcohol Consumption (TAC)
Description
TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
Time Frame
Baseline and Month 6
Secondary Outcome Measure Information:
Title
Drinking Risk Level (RSDRL) Response
Description
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.
Time Frame
Month 6
Title
Change From Baseline in Clinical Status Using CGI-S
Description
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).
Time Frame
Baseline and Week 24
Title
Change in Clinical Status Using the CGI-I
Description
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).
Time Frame
Week 24
Title
Liver Function Test Gamma-glutamyl Transferase (GGT)
Description
GGT values
Time Frame
Week 24
Title
Liver Function Test Alanine Aminotransferase (ALAT)
Description
ALAT values
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
AT001
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
AT004
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AT002
City
Vienna
ZIP/Postal Code
1230
Country
Austria
Facility Name
AT003
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
FI008
City
Helsinki
ZIP/Postal Code
560
Country
Finland
Facility Name
FI009
City
Helsinki
ZIP/Postal Code
800
Country
Finland
Facility Name
FI007
City
Järvenpää
ZIP/Postal Code
4480
Country
Finland
Facility Name
FI013
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
FI004
City
Kuusankoski
ZIP/Postal Code
45700
Country
Finland
Facility Name
FI001
City
Mikkeli
ZIP/Postal Code
50100
Country
Finland
Facility Name
FI015
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
FI003
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
FI002
City
Tampere
ZIP/Postal Code
339000
Country
Finland
Facility Name
FI014
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
FI011
City
Vantaa
ZIP/Postal Code
1600
Country
Finland
Facility Name
DE011
City
Bad Saarow
ZIP/Postal Code
15526
Country
Germany
Facility Name
DE016
City
Berlin
ZIP/Postal Code
10245
Country
Germany
Facility Name
DE005
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
DE002
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
DE017
City
Berlin
ZIP/Postal Code
12524
Country
Germany
Facility Name
DE008
City
Berlin
ZIP/Postal Code
13156
Country
Germany
Facility Name
DE019
City
Berlin
ZIP/Postal Code
13187
Country
Germany
Facility Name
DE003
City
Essen
ZIP/Postal Code
NW 45136
Country
Germany
Facility Name
DE006
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
DE001
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
DE007
City
Leukersdorf
ZIP/Postal Code
09387
Country
Germany
Facility Name
DE003
City
Mannheim
ZIP/Postal Code
BW68159
Country
Germany
Facility Name
DE014
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
DE010
City
Regensburg
ZIP/Postal Code
BY 93053
Country
Germany
Facility Name
DE018
City
Siegen
ZIP/Postal Code
57072
Country
Germany
Facility Name
DE020
City
Wallerfing
ZIP/Postal Code
94574
Country
Germany
Facility Name
SE011
City
Gothenburg
ZIP/Postal Code
402 76
Country
Sweden
Facility Name
SE005
City
Kalmar
ZIP/Postal Code
391 85
Country
Sweden
Facility Name
SE006
City
Linköping
ZIP/Postal Code
857 58
Country
Sweden
Facility Name
SE001
City
Malmo
ZIP/Postal Code
211 22
Country
Sweden
Facility Name
SE004
City
Stockholm
ZIP/Postal Code
118 91
Country
Sweden
Facility Name
SE002
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
SE008
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
SE009
City
Uppsala
ZIP/Postal Code
756 43
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23237314
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.
Results Reference
result
PubMed Identifier
25832297
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.
Results Reference
derived
PubMed Identifier
25227627
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.
Results Reference
derived
PubMed Identifier
23873853
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. Erratum In: Alcohol Alcohol. 2013 Nov-Dec;48(6):746.
Results Reference
derived

Learn more about this trial

Efficacy of Nalmefene in Patients With Alcohol Dependence

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