Oral and extended-release injectable forms of naltrexone produced similar reductions in heavy drinking among hospitalized patients with alcohol use disorder in a randomized clinical trial.
The researchers followed 248 patients at a U.S. urban teaching hospital for 3 months after discharge. Participants were randomly assigned to receive either a daily oral dose or a monthly injection of naltrexone, and both groups received medical management support.
At baseline, participants reported heavy drinking on about 70% of days over the past month. A heavy drinking day was defined as five or more drinks for men or four or more drinks for women. By the 3-month follow-up, average heavy drinking days dropped to 27.4% in the oral group and 23.8% in the injectable group. The difference between the two groups was not statistically significant (adjusted difference = −8.17 percentage points, 95% confidence interval [CI] = −18.97 to 2.62, P = .14).
Emergency department visits or hospitalizations in the 3 months after discharge were reported by 54.1% of oral group participants and 61.1% of those in the injectable group. This difference was also not statistically significant.
The investigators also assessed alcohol use with self-reports and biomarkers. Phosphatidylethanol levels of 20 ng/mL or higher, which indicate recent heavy alcohol use, were found in 75.9% of tested participants and were consistent with their reported drinking behavior.
Medication adherence was higher among those who received the injectable form of naltrexone. In that group, 40.7% received all three scheduled injections, compared with 26.6% of the oral group. Among the oral group, most participants with high self-reported adherence had measurable levels of naltrexone in their blood.
Costs were substantially higher for the injectable form, with a median 3-month cost of $5,208 compared with $1,630 for oral naltrexone. These figures included medication, nurse time, lab testing, and health care use.
Serious adverse events were uncommon and occurred in six patients across both groups. These events included suicide attempts, alcohol withdrawal, palpitations, urinary tract infections, and an injection site abscess.
The investigators concluded that hospitalization offers an opportunity to initiate pharmacologic treatment for alcohol use disorder (AUD). Given the similar outcomes, treatment choice may be guided by patient preference, cost, and likelihood of adherence.
“This study elucidated the real-world comparative effectiveness of treatment between two formulations of an effective AUD medication initiated in the hospital,” wrote Kara M. Magane, MS, of Boston University School of Public Health, with colleagues.
Full disclosures are available in the published study.
Source: JAMA Internal Medicine