Efficacy of Nalmefene in Patients With Alcohol Dependence

Alcohol Dependence Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811720
• Other study ID #: 12014A
• Secondary ID: 2007-002334-11
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2008
• Last updated: July 5, 2013
• Start date: December 2008
• Est. completion date: November 2010

Study information

• Verified date: July 2013
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Placebo
as-needed use, tablets, orally, 6 months
• Nalmefene
18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Locations

Country	Name	City	State
Austria	AT001	Linz
Austria	AT004	Salzburg
Austria	AT002	Vienna
Austria	AT003	Wien
Finland	FI008	Helsinki
Finland	FI009	Helsinki
Finland	FI007	Järvenpää
Finland	FI013	Kuopio
Finland	FI004	Kuusankoski
Finland	FI001	Mikkeli
Finland	FI015	Oulu
Finland	FI002	Tampere
Finland	FI003	Tampere
Finland	FI014	Turku
Finland	FI011	Vantaa
Germany	DE011	Bad Saarow
Germany	DE002	Berlin
Germany	DE005	Berlin
Germany	DE008	Berlin
Germany	DE016	Berlin
Germany	DE017	Berlin
Germany	DE019	Berlin
Germany	DE003	Essen
Germany	DE001	Hamburg
Germany	DE006	Hamburg
Germany	DE007	Leukersdorf
Germany	DE003	Mannheim
Germany	DE014	Munich
Germany	DE010	Regensburg
Germany	DE018	Siegen
Germany	DE020	Wallerfing
Sweden	SE011	Gothenburg
Sweden	SE005	Kalmar
Sweden	SE006	Linköping
Sweden	SE001	Malmo
Sweden	SE002	Stockholm
Sweden	SE004	Stockholm
Sweden	SE008	Stockholm
Sweden	SE009	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Austria,  Finland,  Germany,  Sweden, 

References & Publications (1)

Mann K, Bladström 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 D — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Month 6	No
Primary	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).	Baseline and Month 6	No
Secondary	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.	Month 6	No
Secondary	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).	Baseline and Week 24	No
Secondary	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).	Week 24	No
Secondary	Liver Function Test Gamma-glutamyl Transferase (GGT)	GGT values	Week 24	No
Secondary	Liver Function Test Alanine Aminotransferase (ALAT)	ALAT values	Week 24	No