When is Naltrexone (Revia) indicated for the treatment of Alcohol Use Disorder (AUD)?

From the Guidelines

Naltrexone (Revia) should be used for treating alcohol use disorder in patients who have stopped drinking and want to maintain abstinence or reduce heavy drinking, but only in those without liver dysfunction, as it can cause hepatotoxicity in high doses. The standard oral dose is 50 mg once daily, though some patients may start at 25 mg to minimize side effects, as indicated in the 2013 study 1. Treatment typically continues for at least 3-6 months, but can be maintained longer if beneficial. Naltrexone works best when combined with counseling or behavioral therapy. Before starting treatment, patients should be abstinent from alcohol for at least 3-4 days and should undergo liver function tests, as naltrexone can cause hepatotoxicity in high doses, a concern also noted in the 2020 study 1. It should not be used in patients with acute hepatitis, liver failure, or those taking opioid medications, as naltrexone blocks opioid receptors and can precipitate withdrawal in opioid-dependent individuals. Common side effects include nausea, headache, dizziness, and fatigue, which often diminish over time. Naltrexone works by blocking opioid receptors in the brain, reducing the pleasurable effects of alcohol and decreasing cravings, which helps patients maintain sobriety or reduce drinking episodes.

Some key considerations when using naltrexone include:

• Monitoring liver function tests due to the risk of hepatotoxicity, as highlighted in both the 2013 1 and 2020 1 studies.
• Avoiding use in patients with liver dysfunction, as it can exacerbate liver damage.
• Combining naltrexone with counseling or behavioral therapy for optimal results.
• Starting with a lower dose (25 mg) to minimize side effects and gradually increasing to the standard dose (50 mg) as needed.
• Being aware of potential interactions with opioid medications and avoiding use in patients taking these medications.

It's also important to note that while naltrexone is effective in reducing alcohol cravings and consumption, it should be used as part of a comprehensive treatment plan that includes counseling, support groups, and lifestyle modifications to address the underlying causes of alcohol use disorder. The 2020 study 1 provides guidance on the use of naltrexone and other medications for relapse prevention in patients with alcoholic liver disease, emphasizing the need for careful consideration of liver function and potential hepatotoxicity.

From the FDA Drug Label

Naltrexone hydrochloride tablets USP 50 mg is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. To reduce the risk of precipitated withdrawal in patients dependent on opioids, or exacerbation of a preexisting subclinical withdrawal syndrome, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting naltrexone hydrochloride treatment A dose of 50 mg once daily is recommended for most patients The placebo-controlled studies that demonstrated the efficacy of naltrexone hydrochloride as an adjunctive treatment of alcoholism used a dose regimen of naltrexone hydrochloride 50 mg once daily for up to 12 weeks.

When to Use Naltrexone for Treating Alcohol Use Disorder:

• Naltrexone should be used as part of a comprehensive plan of management for alcohol dependence.
• Patients should be opioid-free for at least 7-10 days before starting naltrexone treatment.
• A dose of 50 mg once daily is recommended for most patients.
• Naltrexone should be considered as only one of many factors determining the success of treatment of alcoholism.
• Factors associated with a good outcome include the type, intensity, and duration of treatment; appropriate management of comorbid conditions; use of community-based support groups; and good medication compliance.
• Treatment should be initiated under the guidance of a healthcare provider, with careful monitoring for signs of opioid withdrawal and other potential side effects 2, 2, 2.

From the Research

Naltrexone (Revia) for Treating Alcohol Use Disorder

• Naltrexone is one of the medications approved by the US Food and Drug Administration (FDA) for the treatment of alcohol use disorder 3.
• It is increasingly being prescribed in American patients with mild and severe alcohol-related liver disease, with a duration of use longer than acamprosate and disulfiram (360 vs 251 vs 190 days) 4.
• A meta-analysis found that naltrexone is 27% more effective than placebo in supporting continuous abstinence, and it increases the total number of abstinence days by 14% 5.

When to Use Naltrexone

• Naltrexone is most helpful in reducing heavy drinking and craving, especially when patients are required to be abstinent before treatment 6.
• Requiring abstinence before the trial is associated with larger effect sizes for abstinence maintenance and reduced heavy drinking compared with placebo 6.
• Naltrexone has been found to be slightly more efficacious in reducing heavy drinking and craving compared to acamprosate 6.

Comparison with Other Medications

• A randomized, multicentre, open-label, comparative trial found that disulfiram was more effective in reducing heavy drinking days and increasing time to first drink, but there were no differences between naltrexone and acamprosate in drinking outcomes 7.
• However, Severity of Alcohol Dependence Data (SADD) scores improved more in the naltrexone group than the acamprosate group 7.
• Acamprosate and naltrexone are both effective in promoting abstinence and reducing heavy drinking, but acamprosate is slightly more efficacious in promoting abstinence 5, 6.