Emergency department-initiated oral naltrexone for patients with moderate to severe alcohol use disorder: A pilot feasibility study

Objectives: Alcohol use disorder (AUD) is the most common substance use disorder in the United States. Despite availability of four FDA-approved medications, fewer than 10% of patients are prescribed medication. This study aimed to evaluate the impact and feasibility of emergency department (ED)-initiated oral naltrexone in patients with moderate to severe AUD. Methods: This was a prospective, single-arm, open-label, nonrandomized clinical trial conducted a single ED. Consenting participants were adults with moderate to severe AUD who were provided a single 50-mg dose of oral naltrexone, a 14-day starter pack of naltrexone, and referral for treatment. Follow-up was conducted at 14 and 30 days post-ED visit. The primary outcome was engagement in formal addiction treatment. Secondary outcomes included alcohol consumption, craving, quality-of-life measures, satisfaction, and safety. Results: Of 761 patients screened, 21 enrolled and received at least one dose of naltrexone. At 14 days, 29% were engaged in treatment, increasing to 33% at 30 days. There was a decrease in the mean (+/- SD) number of drinks per day from 5.20 (+/- 4.67) at baseline to 2.23 (+/- 4.35) during the follow-up period (p = 0.078). There was a decrease in alcohol craving scores, with median scores dropping from 19 at baseline to 8.27 during the follow-up period (p < 0.001). Quality-of-life measures improved, with a statistically significant increase in the reported number of healthy days (p = 0.006) and decrease in depressive symptoms (p < 0.001). Reported side effects were mild and satisfaction with the screening process was high. Conclusions: ED-initiated oral naltrexone is feasible and acceptable for patients with moderate to severe AUD. While engagement in treatment was moderate, significant reductions in alcohol craving and improvements in quality of life suggest potential benefits. Further research is warranted to confirm these findings.