Conditions: Alcohol Dependence
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 678
Healthy volunteers: no

Brief summary:
The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in patients with alcohol dependence will be evaluated in a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol consumption.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Nalmefene hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: As-needed; tablets, orally intervention 2: As-needed; tablets, orally

Protocol document: