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

• Published in: Psychiatry and clinical neurosciences 2019-11, Vol.73 (11), p.697-706
• Main Authors: Miyata, Hisatsugu, Takahashi, Masayoshi, Murai, Yoshiyuki, Tsuneyoshi, Kana, Hayashi, Takako, Meulien, Didier, Sørensen, Per, Higuchi, Susumu
• Format: Article
• Language: English
• Subjects: Adult; Alcohol; alcohol dependence; Alcohol Deterrents - adverse effects; Alcohol Deterrents - therapeutic use; Alcohol Drinking; Alcohol use; Alcoholism - drug therapy; Alcoholism - psychology; Double-Blind Method; Double-blind studies; Drinking behavior; drug therapy; Endpoint Determination; Female; Humans; Male; Middle Aged; Naltrexone - adverse effects; Naltrexone - analogs & derivatives; Naltrexone - therapeutic use; opioid; Regular; Risk; safety; Treatment Outcome
• ISSN: 1323-1316; 1440-1819
• DOI: 10.1111/pcn.12914

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 patients who received placebo, nalmefene 20 mg, and 10 mg were included in the primary endpoint analysis. Compared with placebo, nalmefene was associated with significant reductions in HDD at week 12 (difference in 20 mg group, −4.34 days/month; 95% confidence interval [CI]: −6.05 to −2.62; P