NCT04464980

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,516 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Opioid Use Disorder (OUD)

Interventions

Type	Name	Description
DRUG	SL-BUP	Daily dosing of sublingual buprenorphine-naloxone
DRUG	XR-BUP	Weekly/monthly dosing of extended-release injectable buprenorphine
DRUG	XR-NTX	Monthly dosing of extended-release injectable naltrexone
BEHAVIORAL	MM	MM consists of standard Medical Management and the usual counseling at the treatment program.
BEHAVIORAL	MMR	MMR consists of Medical Management and usual counseling, plus a technology-based behavioral component.
BEHAVIORAL	MMD	MMD consists of Medical Management and usual counseling, plus a technology-based behavioral component.

Timeline

• Start date: 2021-06-08
• Primary completion: 2026-12-31
• Completion: 2027-01-31
• First posted: 2020-07-09
• Last updated: 2025-12-15

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study