ADOPT
Trial question
What is the effect of oral naltrexone compared to extended-release injectable naltrexone in hospitalized patients with alcohol use disorder?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
20.0% female
80.0% male
N = 248
248 patients (49 female, 199 male).
Inclusion criteria: hospitalized patients with alcohol use disorder with recent heavy drinking.
Key exclusion criteria: use of long-acting opioids in the past week or short-acting opioids in the past 24 hours; positive urine results for any opioid; planned discharge prescription for opioids; need for opioids for anticipated painful event or surgery in the next 3 months; current suicidality or psychosis; cognitive dysfunction precluding informed consent; acute hepatitis or liver failure; pregnancy or lactation.
Interventions
N=125 oral naltrexone (at a dose of 25 mg/day for 3 days, then 50 mg/day with titration to potential maximum of 100 mg/day).
N=123 extended-release injectable naltrexone (at a dose of 380 mg IM on day of hospital discharge with second and third doses 1 and 2 months later).
Primary outcome
Reduction in heavy drinking days in past 30 days at 3-month follow-up
38.4%
46.4%
46.4 %
34.8 %
23.2 %
11.6 %
0.0 %
Oral
naltrexone
Extended-release injectable
naltrexone
No significant
difference ↔
No significant difference in reduction in heavy drinking days in the past 30 days at 3-month follow-up (38.4% vs. 46.4%; MD -8.17, 95% CI -18.97 to 2.62).
Secondary outcomes
No significant difference in mean Short Inventory of Problems Revision 2 alcohol-related problem score (13.6 points vs. 15 points; MD -1.48, 95% CI -4.9 to 1.93).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In hospitalized patients with alcohol use disorder with recent heavy drinking, oral naltrexone was equivalent to extended-release injectable naltrexone with respect to reduction in heavy drinking days in the past 30 days at 3-month follow-up.
Reference
Kara M Magane, Kimberly A Dukes, Sarah Fielman et al. Oral vs Extended-Release Injectable Naltrexone for Hospitalized Patients With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2025 Apr 21:e250522. Online ahead of print.
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