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

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.

Conditions

• Opioid Use Disorder (OUD)

Interventions

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.

Sponsors & Collaborators

• New York State Psychiatric Institute

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Harvard Medical School (HMS and HSDM)

  collaborator OTHER

• Mclean Hospital

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• The Emmes Company, LLC

  collaborator INDUSTRY

• NYU Langone Health

  lead OTHER

Principal Investigators

• Edward V Nunes, MD · New York State Psychiatric Institute/Columbia University Irving Medical Center

• John Rotrosen, MD · NYU Langone Health

• Roger Weiss, MD · Harvard Medical School/McLean Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-08

Primary Completion

2026-12-31

Completion

2027-01-31

FDA Drug

Yes

Countries

• United States

Study Locations