Review of studiesNaltrexone for alcohol2023
AHRQ 2023 review: medicines for alcohol use disorder in outpatient care
McPheeters M, O'Connor EA, Riley S, et al. Pharmacotherapy for Adults With Alcohol Use Disorder in Outpatient Settings: Systematic Review (Comparative Effectiveness Review No. 262) — Executive Summary
What it found
Oral naltrexone 50 mg had moderate strength of evidence across several drinking outcomes in this AHRQ review of 118 studies, with a number needed to treat of 18 to prevent a return to any drinking and 11 to prevent a return to heavy drinking. Injectable naltrexone had low strength of evidence for fewer drinking days and heavy drinking days.
- Studies included
- 118
- Number needed to treat, any drinking (oral naltrexone)
- 18
- Number needed to treat, heavy drinking (oral naltrexone)
- 11
- Number needed to treat, any drinking (acamprosate)
- 11
What they tested
The Agency for Healthcare Research and Quality (AHRQ), a US government agency, updated its 2014 review of medicines for alcohol use disorder in outpatient settings. It covered the three medicines with FDA approval for alcohol use disorder (acamprosate, disulfiram and naltrexone, which comes as a pill and an injection) and six used off-label in the US: baclofen, gabapentin, ondansetron, topiramate, varenicline and prazosin.
The team searched for studies published from November 1, 2012, through September 9, 2022, pooled results where possible and graded the strength of the evidence. Trials with less than 12 weeks of follow-up were left out. This page is based on the executive summary, not the full report.
What they found
Naltrexone 50 mg by mouth had moderate strength of evidence for reducing return to any drinking, return to heavy drinking, percent drinking days and percent heavy drinking days. A number needed to treat of 18 means 18 people need to take it for one more person to avoid a return to any drinking.
The 2014 report found no clear benefit for injectable naltrexone. A new trial in people experiencing homelessness showed fewer drinking days and heavy drinking days, raising the evidence for the injection to low strength.
Acamprosate (number needed to treat 11 for any drinking) and topiramate had moderate evidence of benefit. Baclofen and gabapentin had low-strength evidence for some outcomes, and the evidence did not adequately support disulfiram over placebo.
Trials of naltrexone found higher chances of dizziness, insomnia, nausea and vomiting. In head-to-head studies, people on acamprosate had a slightly lower risk of headache and vomiting than people on naltrexone.
There was no convincing evidence that any medicine works better than another for men or women, older or young adults, smokers or people with co-occurring disorders.
Limits
- Few studies measured health outcomes such as injuries or quality of life, and side effects were reported inconsistently.
- Only one trial was done in primary care, so evidence for that setting is scant.
- Nalmefene and other medicines available only outside the US were not part of this update.
- This page is based on the executive summary, not the full report.
What it means if you're considering naltrexone
For someone weighing naltrexone, this review supports oral naltrexone 50 mg as one of the better-supported options, and notes it is a once-daily pill. Acamprosate and topiramate also have evidence of benefit, and the authors say the choice should be made between patient and clinician, based on goals, side effects, other health conditions and how easy the medicine is to keep taking.
The same authors published the pooled results in JAMA in 2023 (McPheeters 2023).
Frequently asked questions
What is the number needed to treat for naltrexone?
In this review, it was 18 to prevent one return to any drinking and 11 to prevent one return to heavy drinking, for oral naltrexone 50 mg.
The paper
McPheeters M, O'Connor EA, Riley S, et al. Pharmacotherapy for Adults With Alcohol Use Disorder in Outpatient Settings: Systematic Review. Executive summary. Comparative Effectiveness Review No. 262. AHRQ Publication No. 23(24)-EHC011. Agency for Healthcare Research and Quality; November 2023. Accessed October 17, 2026. doi:10.23970/AHRQEPCCER262
Read the reviewdoi:10.23970/AHRQEPCCER262
We wrote this page from the report's published summary, 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.