Discontinuation of medication treatment for opioid use disorder after a successful course: The discontinuation phase of the CTN-0100 (RDD) trial

Matisyahu Shulman; Scott Provost; Kaitlyn Ohrtman; Patricia Novo; Sarah Meyers-Ohki; Paul Van Veldhuisen; Neal Oden; Michael Otterstatter; Genie L Bailey; David Liu; John Rotrosen; Edward V Nunes; Roger D Weiss

doi:10.1016/j.cct.2024.107543

Discontinuation of medication treatment for opioid use disorder after a successful course: The discontinuation phase of the CTN-0100 (RDD) trial

Contemp Clin Trials. 2024 Apr 23:142:107543. doi: 10.1016/j.cct.2024.107543. Online ahead of print.

Authors

Affiliations

¹ New York State Psychiatric Institute, USA; Columbia University Irving Medical Center, USA. Electronic address: matisyahu.shulman@nyspi.columbia.edu.
² Mass General Brigham McLean, USA.
³ New York State Psychiatric Institute, USA.
⁴ New York University Grossman School of Medicine, USA.
⁵ The Emmes Company, LLC, USA.
⁶ Warren Alpert School of Medicine of Brown University / Stanley Street Treatment and Resources, Inc., USA.
⁷ National Institute on Drug Abuse, USA.
⁸ New York State Psychiatric Institute, USA; Columbia University Irving Medical Center, USA.

PMID: 38657730
DOI: 10.1016/j.cct.2024.107543

Abstract

Introduction and background: Buprenorphine, and extended-release naltrexone, are effective in decreasing opioid use, morbidity and mortality. The available evidence suggests that these medications should be used for long term treatment; however, patients often ask how long they need to be on medication, and whether it would be safe to discontinue. There are sparse data to guide us. The CTN-0100 trial will address this gap in our knowledge by studying participants who have decided to discontinue buprenorphine and extended-release naltrexone for OUD.

Research design and methods: The trial is a multicenter, randomized, non-blinded study. Participants are stable adult volunteers, on sublingual buprenorphine, extended-release buprenorphine, or extended-release naltrexone, expressing an interest in discontinuing medication. Participants on buprenorphine must be stable for at least 1 year and participants on extended-release naltrexone must be stable for at least 6 months. Participants are engaged in the study for up to 96 weeks, including a flexible taper period, and are then transitioned to follow-up within the trial. All participants are randomly assigned to the study Medical Management (MM) or to MM plus Connections (CHESS health) digital smartphone application aimed at recovery and abstinence (MMD). Sublingual Buprenorphine participants are also randomized (2 × 2 design) to a taper using either sublingual or extended-release buprenorphine.

Discussion/conclusion: It is hoped that this trial will provide a rich source of data on management of patients discontinuing medication for opioid use disorder (MOUD) to inform future research and practice. The trial will shed light on which strategies are most likely to lead to long-term success (absence of relapse), and what participant characteristics distinguish those who can safely discontinue MOUD from those who remain at risk of relapse should they discontinue.

Clinicaltrials: gov Identifier: NCT04464980.

Keywords: Automated psychosocial intervention; Buprenorphine; Naltrexone; Opioid use disorder; Opioids; Treatment.

Associated data

ClinicalTrials.gov/NCT04464980