Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

Opioid Use Disorder (OUD) Clinical Trial

Official title: NIDA-CTN-0100: Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Opioid Use Disorder (OUD)
• Opioid-Related Disorders
• Substance-Related Disorders

• 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