What is the dosing regimen for Naltrexone (Naltrexone) for the treatment of alcohol use disorder?

From the Guidelines

Naltrexone for alcohol use disorder is typically prescribed at a dose of 50 mg once daily by mouth, with an initial dose of 25 mg for the first 1-3 days to minimize side effects. Treatment usually begins after the patient has stopped drinking and is no longer experiencing acute alcohol withdrawal. The medication works by blocking opioid receptors in the brain, which reduces the pleasurable effects of alcohol and helps decrease cravings 1. Naltrexone should be taken consistently for maximum effectiveness, and treatment duration is typically at least 3-6 months, though some patients benefit from longer treatment. It's essential to note that naltrexone should not be taken by patients who are using opioid medications or who have acute hepatitis or liver failure, as it can cause toxic liver injury 1. Regular liver function monitoring is recommended, especially in the first few months of treatment, with liver function tests at baseline and every three to six months 1. For optimal results, naltrexone should be used as part of a comprehensive treatment program that includes counseling or behavioral therapy. Some key points to consider when prescribing naltrexone include:

• Starting with a lower dose of 25 mg for the first 1-3 days to minimize side effects like nausea, headache, or dizziness
• Monitoring liver function regularly, especially in the first few months of treatment
• Using naltrexone as part of a comprehensive treatment program that includes counseling or behavioral therapy
• Avoiding use in patients with acute hepatitis or liver failure, or those using opioid medications.

From the FDA Drug Label

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.

The recommended dose of naltrexone for alcohol use is 50 mg once daily. Patients should be opioid-free before starting treatment, with a minimum of 7 to 10 days since last opioid use 2.

From the Research

Dosing Naltrexone for Alcohol Use

• The dosing of naltrexone for alcohol use is not explicitly stated in the provided studies, but the typical dosage can be inferred from the study contexts.
• In the study 3, a single 50-mg dose of oral naltrexone was provided to patients, and they were also given a 14-day starter pack of naltrexone.
• The study 4 mentions that naltrexone was administered at a dose of 50 mg per day.
• It is essential to note that the dosing of naltrexone may vary depending on the specific treatment protocol and the patient's individual needs.

Administration and Efficacy

• Naltrexone can be administered orally, and it has been shown to reduce relapse rates and cravings, and increase abstinence rates in patients with alcohol use disorder 5, 6, 7.
• The study 3 found that ED-initiated oral naltrexone was feasible and acceptable for patients with moderate to severe AUD, and it resulted in significant reductions in alcohol craving and improvements in quality of life.
• The study 4 compared the effects of disulfiram, naltrexone, and acamprosate in the treatment of alcohol dependence and found that all three medications were effective in reducing drinking, but disulfiram appeared to be superior, especially during the continuous medication period.

Safety and Tolerability

• The study 6 found that the rate of alcohol use disorder medication discontinuation for adverse events was similar in both groups (14% vs 12%).
• The study 3 reported that side effects were mild, and satisfaction with the screening process was high.
• The study 4 did not report any significant differences in safety and tolerability between the three medications.