A groundbreaking clinical trial led by researchers at Boston University has illuminated a promising avenue for improving treatment outcomes among hospitalized patients grappling with alcohol use disorder (AUD). This study, published in JAMA Internal Medicine, decisively demonstrates that initiating medication for AUD during a hospital stay—specifically utilizing the drug naltrexone—can lead to significant reductions in heavy alcohol consumption in the crucial months following discharge. The implications position hospital settings as pivotal intervention points for addressing a chronic condition that affects nearly 30 million American adults yet remains vastly undertreated.
Alcohol use disorder represents a profound public health challenge, characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. Yet despite its prevalence, the majority of individuals with AUD are not engaged in effective treatment regimens. The complex interplay of addiction biology, social determinants, and healthcare access barriers creates a treatment gap that has persisted for decades. The new Boston University study offers compelling evidence that integrating pharmacotherapy initiation into inpatient care protocols may be an effective strategy to close this gap and improve patient outcomes.
The study methodically compared two formulations of naltrexone: an oral pill taken daily, and an extended-release injectable administered monthly. Both forms act as opioid antagonists that modulate the brain’s reward circuitry by blocking the euphoric effects of alcohol, thereby decreasing cravings and heavy drinking episodes. Until now, randomized clinical trial data directly comparing these two formulations’ real-world effectiveness had been lacking. The current research fills that void by enrolling 248 hospitalized individuals diagnosed with AUD and randomizing them to receive either the oral or injectable naltrexone at discharge, then carefully tracking their alcohol consumption over the subsequent three months.
Remarkably, both formulations yielded substantial reductions in heavy drinking days over the three-month follow-up. Patients adhering to the daily oral regimen experienced approximately a 38 percentage-point drop in heavy drinking within the prior 30 days, while those receiving the extended-release injectable saw an even more pronounced 46 percentage-point decrease. This equivalence in clinical efficacy underscores the versatility of naltrexone therapy, allowing personalized choices based on patient preferences, tolerability, and logistical considerations without compromising therapeutic benefits.
One of the notable technical insights revealed by this trial concerns medication adherence. Consistent with earlier observations, adherence rates were modestly higher for the injectable naltrexone, likely attributable to its once-monthly dosing regimen that circumvents the challenge of daily pill-taking. However, the study authors highlight that adherence in the context of a clinical trial, with structured follow-up, may not fully recapitulate real-world conditions where patients must negotiate complex socioeconomic and healthcare system barriers. Still, the findings suggest that offering patients flexibility in selecting their preferred dosage form, informed by careful clinician-patient dialogue, could optimize adherence and enhance outcomes.
Beyond the pharmacokinetic and behavioral dimensions, the study sheds light on the economic and logistical trade-offs intrinsic to each formulation. The injectable naltrexone incurs notably higher upfront costs—exceeding $1,000 per injection when billed through Medicare Part B—compared to approximately $38 for 30 days of oral pills dispensed under Medicare Part D. Moreover, injectable administration necessitates clinic visits for intramuscular injection, potentially imposing additional access hurdles. These cost and operational factors complicate decisions around widespread adoption, especially in resource-constrained hospital settings. The study thus advocates for nuanced policy and reimbursement frameworks that can accommodate both formulations to maximize patient-centered care.
The researchers also examined clinical endpoints beyond consumption patterns, notably acute hospital readmissions and AUD-related healthcare utilization during the three-month post-discharge window. Interestingly, the initiation of naltrexone in either formulation did not correlate with statistically significant differences in hospital visits within this timeframe. This observation suggests that while naltrexone effectively reduces heavy drinking—a key driver of morbidity—the broader impact on healthcare utilization may require longer follow-up durations or complementary psychosocial interventions alongside pharmacotherapy to manifest measurable reductions.
A striking feature of this research is the recognition of the unique opportunity hospitals provide to intercept a traditionally underserved population. Hospitalizations often represent critical “teachable moments” when patients may be more receptive to interventions for their AUD, given the acute health consequences that precipitated their admission. Yet historically, AUD has suffered from underdiagnosis and suboptimal management in inpatient settings, overshadowed by the immediacy of acute medical issues. By embedding AUD pharmacotherapy into discharge planning, hospitals can pivot from episodic care towards sustained management of this chronic illness.
Dr. Jeffrey Samet, the study’s corresponding author and a clinician-scientist with profound expertise in addiction medicine, underscores the transformative potential of these findings. He contends that initiating evidence-based treatment during hospitalization can catalyze durable improvements in AUD outcomes, effectively bridging a care gap that has persisted despite well-characterized pharmacologic options. This robust clinical trial provides the empirical foundation necessary to reframe hospital care protocols and incentivize system-wide integration of addiction treatment services.
The study also honors the legacy of Dr. Richard Saitz, a pioneering figure in addiction research and the original principal investigator. His vision and meticulous scientific rigor continue to influence the field profoundly. Completion and publication of these findings posthumously reflect a tribute to his commitment to advancing accessible, compassionate care for people with substance use disorders.
Funding for this research was provided by the National Institute on Alcohol Abuse and Alcoholism, supplemented by contributions from Alkermes and the United States Drug Testing Laboratories. The interdisciplinary research team comprised experts spanning Boston University’s School of Public Health and School of Medicine, Boston Medical Center, South Shore Hospital, and the University of Pittsburgh School of Medicine, reflecting a collaborative approach essential for tackling complex addiction challenges.
Looking ahead, the research team emphasizes the necessity of complementary studies to unpack patient-centered factors influencing medication adherence, including social determinants such as housing stability and access to post-discharge care. Understanding patient preferences in formulation choice and optimizing delivery models in diverse clinical settings remain vital for translating these clinical trial successes into real-world impact.
Ultimately, this study delivers a compelling call to action: effective, evidence-based pharmacologic treatments for alcohol use disorder exist and can be successfully initiated in hospital settings. Moving beyond the siloed management of acute issues, healthcare systems must embrace addiction treatment as a fundamental component of routine inpatient care. Such paradigm shifts stand to alleviate the immense individual and societal burdens imposed by AUD and pave the way towards more equitable and effective public health interventions.
Subject of Research: People
Article Title: Oral vs Extended-Release Naltrexone for Hospitalized Patients with Alcohol Use Disorder
News Publication Date: 21-Apr-2025
Web References:
- https://doi.org/10.1001/jamainternmed.2025.0522
- https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-use-disorder-aud-united-states-age-groups-and-demographic-characteristics
References:
Magane K, Cheng DM, Samet JH, et al. Oral vs Extended-Release Naltrexone for Hospitalized Patients with Alcohol Use Disorder. JAMA Internal Medicine. Published April 21, 2025. doi:10.1001/jamainternmed.2025.0522
Keywords:
Alcoholism; Hospitals; Clinical research; Public health; Drug therapy; Drug studies; Drug costs; Health care delivery; Scientific data; Urban populations; Drug delivery systems; Addiction; Substance related disorders
