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Clinical Trial Summary

This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.


Clinical Trial Description

The main objectives of this study are: 1. To test strategies to improve retention in treatment on medications for opioid use disorder (MOUD), among patients initiating treatment for OUD. 2. To test strategies to improve outcomes among patients who have achieved stable remission on MOUD and want to discontinue MOUD. 3. To develop models to predict who is able to discontinue MOUD without relapse, based on patient characteristics, including duration of MOUD prior to discontinuation. The study will have a multicenter, randomized, pragmatic non-blinded design. The study has two phases, a Retention Phase and a Discontinuation Phase. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04464980
Study type Interventional
Source NYU Langone Health
Contact Project Manager
Phone 646-754-4786
Email RDD@nyulangone.org
Status Recruiting
Phase Phase 2
Start date June 8, 2021
Completion date December 30, 2026

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