Nalmefene in alcohol-dependent patients with a high drinking risk: Randomized controlled trial.

ABSTRACT:

Aims

Reducing alcohol consumption is one treatment approach for alcohol-dependent patients. This study compared nalmefene 20 mg and 10 mg with placebo, combined with psychosocial support, in alcohol-dependent Japanese patients with a high or very high drinking risk level (DRL).

Methods

This was a multicenter, randomized, double-blind, phase 3 study conducted in alcohol-dependent patients with a high or very high DRL. Patients were randomized to 24 weeks of treatment with as-needed nalmefene 20 mg, 10 mg, or placebo with psychosocial support. The primary endpoint was change in heavy drinking days (HDD) from baseline to week 12. A key secondary endpoint was the change in total alcohol consumption (TAC) from baseline to week 12.

Results

At week 12, 234, 206, and 154 pati

SUBMITTER: Miyata H 

PROVIDER: S-EPMC6899457 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature