Conditions: Alcohol Dependence
Keywords: Alcohol-Related Disorders Alcoholism Mental Disorders Central Nervous System Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 598
Healthy volunteers: no

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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Placebo intervention 2: Nalmefene
Intervention descriptions: intervention 1: as-needed use, tablets, orally, 6 months intervention 2: 18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Protocol document: