Taking another look at extended-release naltrexone for AUD

LAIs by the numbers

57.1% of members on LAI were retained in treatment for 6 months vs. 28.1% on oral naltrexone

Members on LAI had twice the rate of treatment retention at 6 months compared to those on an oral

Members stayed on injectables longer than orals (168 vs 96 days)

Relapse using LAI 0.7%, vs 14% using oral during 24-week trial

Readmission rate for LAI (2.86%) vs. control group (25.7%)

LAI associated with reduced readmissions (odds ratio 8.5%)

LAI % abstinence (41.3-42.7%) vs. placebo (5.0%) up to 24 weeks

Long-Acting naltrexone (vivitrol)

Evidence-based research reports that Alcohol use disorder (AUD) is a chronic medical condition that affects more than 15 million individuals in the United States and accounts for 6% of deaths worldwide. Current clinical recommendations indicate that AUD is a multifactorial medical condition that should be treated in the same manner as other chronic relapsing medical conditions. Multidisciplinary treatment programs that include psychosocial and pharmacologic interventions have proven to be the most efficacious with positive clinical outcomes comparable to other types of complex medical conditions like asthma and diabetes. Long-Acting naltrexone (vivitrol), approved by the FDA in 2010 to treat AUD, combined with psychosocial interventions, reduce cravings, decrease heavy drinking days, reduce readmission rates, increase abstinence rates, and improves community tenure in outpatient treatment programs.

Clinical Practice Guidelines: 

American Psychiatric Association: Naltrexone is recommended as a suitable pharmacologic option to treat moderate-to-severe alcohol abuse and dependence. Naltrexone has the best available evidence for the treatment of AUD and the APA recommends that naltrexone be offered to moderate-to-severe AUD patients. The guidance reports that long-acting IM naltrexone may improve adherence, but oral therapy may be appropriate if compliance is not a concern.

SAMHSA: Extended-release Injectable naltrexone benefits people appropriate for treatment with oral naltrexone, as well as patients who are abstinent at initiation of treatment. Extended-release injectable naltrexone has not been shown to be effective in patients who are drinking at the time treatment is initiated. Low rates of retention and adherence may improve with extended-release naltrexone.

Department of Veterans Affairs/Department of Defense: Updated 2021 guidance includes strong recommendations for the use of naltrexone for pharmacotherapy for patients with moderate to severe AUD.

Safety: Overall, naltrexone is well tolerated. However, the medication can precipitate severe opioid withdrawal in patients who are opioid dependent. Common side effects include nausea, vomiting, headaches, dizziness, fatigue, anxiety, and somnolence. Naltrexone is a Pregnancy Category C risk factor and is excreted into the breast milk. Both the oral and injectable forms of naltrexone carry FDA black box warnings for hepatotoxicity.