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Alcohol Disorder hOsPital Treatment Trial

NCT02478489 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2021-06-29

Study results available
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Summary

The specific aims of this pragmatic randomized controlled trial are to compare initiating injectable extended release naltrexone (XR-NTX) or oral naltrexone (PO-NTX) at the time of discharge from a medical hospitalization for patients with alcohol use disorder (AUD) on: 1) alcohol consumption and consequences, and 2) acute healthcare utilization (including hospital readmission and emergency visits) and cost-effectiveness. In exploratory analyses, the investigators will assess moderators of medication effects including demographic, behavioral, and genetic factors.

Conditions

Interventions

DRUG

Oral naltrexone (PO-NTX)

oral naltrexone

DRUG

Extended-release injectable naltrexone (XR-NTX)

injectable naltrexone

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Boston University

    lead OTHER

Principal Investigators

  • Richard Saitz, MD, MPH · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-07-31
Completion
2020-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02478489 on ClinicalTrials.gov