From the FDA Drug Label
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 duration of naltrexone treatment is up to 12 weeks for the treatment of alcoholism, as demonstrated in placebo-controlled studies 1.
- The treatment duration may vary depending on individual patient needs and response to treatment.
- Comprehensive management plans and medication compliance are crucial for achieving the best possible treatment outcome.
From the Research
The duration of naltrexone treatment should be at least 12 weeks, with some individuals benefiting from treatment for 3-12 months for alcohol use disorder and at least 12 months for opioid use disorder, as supported by the most recent and highest quality study 2.
Key Considerations
- Naltrexone treatment should continue as long as it provides benefit and the patient remains motivated, with regular follow-up appointments to monitor side effects and adjust treatment as needed.
- The decision to discontinue naltrexone should be made collaboratively between the patient and healthcare provider, with a gradual tapering plan to minimize relapse risk.
- Naltrexone works by blocking opioid receptors, reducing cravings and the rewarding effects of substances, and is associated with lower rates of return to heavy drinking, with a number needed to treat of 11 (95% CI, 5-41) for oral naltrexone at a dose of 50 mg/d 2.
Treatment Details
- For alcohol dependence, patients often take 50mg daily, while opioid dependence may require 50mg daily orally or extended-release injectable naltrexone (Vivitrol) 380mg monthly.
- Before starting naltrexone, patients must be opioid-free for 7-10 days to avoid precipitating withdrawal.
- Regular follow-up appointments are essential to monitor side effects, which may include nausea, headache, dizziness, and liver function changes.
Evidence Summary
- A systematic review and meta-analysis of 118 clinical trials and 20,976 participants found that oral naltrexone at 50 mg/d was associated with lower rates of return to heavy drinking, with a number needed to treat of 11 (95% CI, 5-41) 2.
- Injectable naltrexone was associated with fewer drinking days over the 30-day treatment period (weighted mean difference, -4.99 days; 95% CI, -9.49 to -0.49 days) 2.
- Adverse effects of naltrexone included higher gastrointestinal distress, including nausea and vomiting, compared with placebo 2.