Efficacy of Nalmefene in Patients With Alcohol Dependence

H. Lundbeck A/S678 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

678

Conditions

Alcohol Dependence

Interventions

PlaceboDRUG

as-needed use, tablets, orally, 6 months

NalmefeneDRUG

18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (57)

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Month 6

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).

Time frame: Baseline and Month 6

Secondary Outcomes

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.

Time frame: Month 6

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).

Time frame: Baseline and Week 24

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).

Time frame: Week 24

Liver Function Test Gamma-glutamyl Transferase (GGT)

Data from ClinicalTrials.gov

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BE002

Assebroek, Belgium

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Liège, Belgium

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Ostend, Belgium

CZ001

Litoměřice, Czechia

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CZ003

Prague, Czechia

...and 47 more locations