Skip to main content
NaltrexoneReviews home

Review of studiesNaltrexone for alcohol2010Landmark study

Rösner 2010 (Cochrane): naltrexone and nalmefene for alcohol

Rösner S, Hackl-Herrwerth A, Leucht S, Vecchi S, Srisurapanont M, Soyka M. Opioid antagonists for alcohol dependence

What it found

Across 50 trials with 7,793 patients, naltrexone reduced the risk of heavy drinking to 83% of the risk on placebo (RR 0.83). Its effect on whether people returned to any drinking (RR 0.96) just missed statistical significance.

Risk of heavy drinking vs placebo
RR 0.83
Drinking days (mean difference)
MD -3.89
Return to any drinking vs placebo
RR 0.96
Extra risk of nausea
RD 0.10

What they tested

A Cochrane review, which pools the results of many trials using strict rules, gathered every double-blind randomized trial comparing naltrexone or nalmefene (a related drug) with a placebo (dummy pill) or another treatment on drinking outcomes. Searches ran through January 2010, and the authors asked drug makers and researchers about unpublished trials.

Two authors pulled out the data independently, and trial quality was checked by two authors.

What they found

Naltrexone lowered the risk of heavy drinking to 83% of the placebo risk (RR 0.83, 95% CI 0.76 to 0.90) and reduced drinking days by about 4% (MD -3.89).

It also improved heavy drinking days (MD -3.25), amount of alcohol consumed (MD -10.83) and gamma-glutamyltransferase, a liver blood test linked to drinking (MD -10.37). Its effect on return to any drinking (RR 0.96, 95% CI 0.92 to 1.00) missed statistical significance.

The main side effects were stomach problems such as nausea (RD 0.10) and sedation such as daytime sleepiness (RD 0.09).

Based on few studies, the effects of injectable naltrexone and of nalmefene missed statistical significance.

Industry-funded trials (RR 0.90, 95% CI 0.78 to 1.05) did not differ significantly from non-profit trials (RR 0.84), and a statistical test didn't find signs of publication bias (P = 0.765).

Limits

  • The searches ended in January 2010, so later trials aren't included.
  • Results for injectable naltrexone and nalmefene rest on a limited number of studies.
  • The authors described the treatment effects as moderate in size.

What it means if you're considering naltrexone

This is one of the largest pooled analyses of naltrexone for alcohol. Its clearest effect is on heavy drinking rather than on keeping people from drinking at all, which matches the site's guides: naltrexone leans toward reducing heavy drinking, while acamprosate leans toward abstinence.

The authors called naltrexone effective and safe, and argued that moderate effects should be weighed against how often alcohol problems relapse and how few treatments exist.

Frequently asked questions

How effective is naltrexone for alcohol according to Cochrane?

The 2010 Cochrane review of 50 trials found naltrexone reduced the risk of heavy drinking to 83% of the risk on placebo (RR 0.83). It had no statistically significant effect on whether people drank at all.

Does naltrexone make you sleepy?

Daytime sleepiness was one of the side effects more common on naltrexone than placebo in this review (risk difference 0.09), along with nausea.

The paper

Rösner S, Hackl-Herrwerth A, Leucht S, Vecchi S, Srisurapanont M, Soyka M. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev. 2010;(12):CD001867. doi:10.1002/14651858.CD001867.pub3

Read the reviewdoi:10.1002/14651858.CD001867.pub3

We wrote this page from the paper's published abstract, and the study's numbers here come from there. Updated October 17, 2026.

Medical disclaimer

This page is for information only and is not medical advice, diagnosis, or treatment. Don't start, stop, or change any medicine — including naltrexone — without your prescriber. Naltrexone must not be used by people taking opioid pain medicines, people dependent on opioids, or people in opioid withdrawal (FDA label). In an emergency call 911; for crisis support call or text 988. Full medical disclaimer.