Oral vs Extended-Release Injectable Naltrexone for Hospitalized Patients With Alcohol Use Disorder: A Randomized Clinical Trial.

IMPORTANCE

Alcohol use disorder (AUD) is common in hospital patients. AUD medications are not typically initiated in that setting. The comparative effectiveness between initiation of oral naltrexone and extended-release injectable naltrexone in the hospital is not known.

OBJECTIVE

To compare the effectiveness of initiating oral naltrexone vs extended-release injectable naltrexone on reduction in alcohol use and health care utilization among medical inpatients with AUD.

DESIGN, SETTING, AND PARTICIPANTS: The Alcohol Disorder Hospital Treatment (ADOPT) study is a randomized clinical trial conducted at an urban teaching hospital in the US, with enrollment between June 2016 and March 2020. Inpatients were screened for eligibility, and those with AUD and recent heavy drinking (defined as 5 or more drinks for men and 4 or more drinks for women) were enrolled. Outcomes were assessed at 3-month follow-up; assessors were not blinded to treatment assignment. Data were analyzed from May 2021 to September 2023.

INTERVENTIONS

Participants received either daily oral naltrexone or monthly extended-release injectable naltrexone. All received medical management with a research nurse who specialized in addiction.

MAIN MEASURES AND OUTCOMES

The primary outcome was change in percentage of heavy drinking days (HDDs) over the past 30 days from baseline to 3-month follow-up, assessed by validated instrument. The secondary outcome was any acute health care utilization (emergency department or hospitalization) at 3-month follow-up over the past 90 days.

RESULTS

Of 248 participants, 199 (80.2%) were male, and the mean (SD) age was 49.4 (10.4) years. The baseline median (IQR) percentage of HDDs in the past 30 days was 80.0% (43.3-100). At 3-month follow-up, the mean percentage of HDDs in the past 30 days was reduced in both groups (oral naltrexone: baseline, 66.7% HDDs; 3-month follow-up, 27.4% HDDs; difference, -38.4 percentage points; 95% CI, -125.0 to 48.2; extended-release injectable naltrexone: baseline, 70.7% HDDs; 3-month follow-up, 23.8% HDDs; difference, -46.4 percentage points; 95% CI, -123.4 to 30.6; P = .14). At follow-up, 59 of 109 in the oral naltrexone arm (54.1%) and 66 of 108 in the extended-release injectable naltrexone arm (61.1%) reported acute health care utilization in the prior 3 months; the odds of this utilization were not significantly different between groups (adjusted odds ratio, 1.34; 95% CI, 0.77-2.33).

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, when initiated at hospital discharge, oral and extended-release injectable naltrexone did not differ in effectiveness. Participants had substantial reductions in HDDs in both treatment groups; however, there was not a significant difference in the reduction of percentage of HDDs in the past 30 days or acute health care utilization between groups. Hospitalization represents an opportunity to start AUD pharmacotherapy; choice of oral naltrexone vs extended-release injectable naltrexone should be directed by factors such as patient preference and insurance.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02478489.