What is the protocol for using naltrexone (Naltrexone) for the treatment of Alcohol Use Disorder (AUD)?

From the Guidelines

Naltrexone should be used with caution in patients with alcohol use disorder, typically prescribed as a 50mg oral tablet taken once daily or as a monthly 380mg extended-release injection, and should be combined with counseling or behavioral therapy for best results. The medication works by blocking opioid receptors in the brain, reducing alcohol cravings and the pleasurable effects of drinking, which helps decrease consumption and prevent relapse 1.

Important Considerations

• Naltrexone should not be taken by people who use opioid medications or have acute hepatitis or liver failure, as it can cause hepatotoxicity 1.
• Treatment duration varies by individual, but typically continues for at least 3-6 months and can be safely used for a year or longer if beneficial 1.
• Patients should carry medical identification indicating they take naltrexone, as it affects how emergency pain medications would work.
• Common side effects include nausea, headache, dizziness, and fatigue, which often improve over time 1.

Key Points to Consider

• Abstinence is the most important therapeutic intervention for patients with alcoholic liver disease, and naltrexone can help maintain abstinence by reducing the craving for alcohol 1.
• The use of naltrexone in patients with liver-function abnormalities or renal failure is limited, and more studies are required to obtain evidence of its efficacy and safety in these patients 1.
• Acamprosate and baclofen are alternative medications that can be used to reduce withdrawal symptoms and maintain abstinence in patients with alcohol use disorder, but their effects on survival are not yet known 1.

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.

Naltrexone for Alcohol Use Disorder:

• The recommended dose is 50 mg once daily for most patients.
• Patients should be opioid-free for at least 7 to 10 days before starting naltrexone hydrochloride treatment to reduce the risk of precipitated withdrawal.
• Naltrexone hydrochloride should be considered as only one of many factors determining the success of treatment of alcoholism, and compliance-enhancing techniques should be implemented to achieve the best possible treatment outcome 2.

From the Research

Naltrexone for Alcohol Use Disorder

• Naltrexone is an approved drug for the management of alcohol use disorder (AUD) 3, 4, 5.
• The medication has been shown to be safe to use in patients with underlying liver disease, including those with compensated cirrhosis 3.
• Studies have demonstrated that naltrexone can reduce the percentage of heavy-drinking days and craving scores in patients with AUD 6, 5.

Administration and Dosage

• Naltrexone can be administered orally or through extended-release intramuscular injection 7, 5.
• The recommended oral dose is 50 mg per day 6, 5.
• Injectable naltrexone has been associated with fewer drinking days over a 30-day treatment period 5.

Combination with Other Therapies

• Naltrexone can be used in combination with cognitive behavioral therapy (CBT) to improve treatment outcomes for AUD 6.
• Substance use navigation has been used in conjunction with naltrexone to improve follow-up rates in formal addiction treatment 7.

Efficacy and Safety

• Meta-analyses have shown that oral naltrexone is associated with lower rates of return to heavy drinking, with a number needed to treat of 11 5.
• Common adverse effects of naltrexone include gastrointestinal distress, nausea, and vomiting 5.
• Naltrexone has been shown to be well-tolerated, with no patients discontinuing the study due to side effects in one study 6.