Principal Investigator

Richard Saitz, MD, MPH, Boston University Schools of Medicine and Public Health

Key Personnel

Debbie Cheng, ScD, Biostatistician, Boston University School of Public Health

Henri Lee, MD, Co-Investigator, Boston University School of Medicine

Tibor Palfai, PhD, Co-Investigator, Boston University School of Psychological and Brain Sciences

Jeffrey Samet, MD, MA, MPH, Co-Investigator, Boston University Schools of Medicine and Public Health

Project Manager

Kara Magane, MPH


Danny Regan, PMHNP, Research Nurse

Stephanie Loomer, MS, Project Coordinator

Devon Dunn, Research Assistant

Grant Abstract

The Alcohol Disorder hosPital Treatment (ADOPT) Study (also known as, Oral v. Injection Naltrexone in Hospital: Comparative Effectiveness for Alcoholism) aims to test the effectiveness of beginning extended-release injectable naltrexone (XR-NTX) and oral naltrexone (PO-NTX) for alcohol use disorder (AUD) in medical inpatients at the time of hospital discharge in a pragmatic comparative effectiveness randomized trial. Inpatients will receive counseling in the hospital and at follow-up that is feasible in medical settings, and be randomly assigned to monthly XR-NTX or daily PO-NTX. The primary outcome is percent heavy drinking days; additional outcomes of interest include alcohol consequences, medical healthcare utilization (hospital and emergency department), AUD treatment utilization, and costs.

The main hypothesis is that XR-NTX will have greater effectiveness than PO-NTX on drinking, consequences, and healthcare utilization.

The specific aims of this pragmatic RCT are to compare initiating XR-NTX to PO-NTX at the time of discharge from a medical hospitalization for patients with AUD on:

1) Alcohol consumption and consequences, and

2) Acute healthcare utilization (including hospital readmission and emergency visits) and cost-effectiveness

Cost-effectiveness analysis will compare the costs and outcomes of the two alternatives. Patient factors that moderate effectiveness will be explored. The study is innovative in its design as a pragmatic comparative effectiveness trial, and because it addresses a question that is unanswered. It is timely in that a national accreditation body has finalized a quality performance measure of AUD pharmacotherapy at hospital discharge despite the absence of evidence for effectiveness in that circumstance. The significance of the study is that results will provide guidance for clinicians and policymakers regarding initiation of pharmacotherapy for AUD for patients at high risk for costly health consequences who largely receive no effective care at the time of hospital discharge.