Optimizing Retention Strategies for Opioid Use Disorder Pharmacotherapy: The Retention Phase of the CTN-0100 Trial (RDD)

Overview

Journal Contemp Clin Trials

Publisher Elsevier

Date 2025 Jan 22

PMID 39842691

Authors

Matisyahu Shulman

Sarah Meyers-Ohki

Patricia Novo

Scott Provost

Kaitlyn Ohrtman

Paul Van Veldhuisen

Neal Oden

Michael Otterstatter

Genie L Bailey

David Liu

John Rotrosen

Roger D Weiss

Edward V Nunes

Affiliations

Soon will be listed here.

Abstract

Introduction And Background: The three medications approved to address OUD are effective in decreasing opioid use and morbidity and mortality; however, their utility is limited by high rates of dropout from treatment. The CTN-0100 trial will develop an evidence base for strategies to improve retention on buprenorphine and extended-release naltrexone.

Research Design And Methods: The National Drug Abuse Treatment Clinical Trials Network (CTN) study CTN-0100, "Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy" (RDD), is a multicenter, randomized, non-blinded trial enrolling more than a thousand patients from 18 community-based substance use disorder treatment programs. Participants are adult volunteers seeking to initiate medication treatment for OUD (MOUD). Individuals choose between buprenorphine or extended-release injectable naltrexone. The trial randomizes participants choosing buprenorphine, in a 3 × 2 factorial design, to a medication condition (standard-dose sublingual buprenorphine, high-dose sublingual buprenorphine, or extended-release injectable buprenorphine) and to a behavioral condition (Medical Management or Medical Management plus a digital therapeutic (smartphone) app). Individuals choosing extended-release naltrexone are randomized only to a behavioral condition. Participants receive study medication for 74 weeks and are then followed for a further 24 weeks. The primary outcome is successful retention on MOUD at 26 weeks (six months), with 50- and 74-week retention among the secondary outcomes.

Discussion/conclusion: Dropout from treatment is a major barrier to the effectiveness of MOUD. The CTN-0100 study will determine whether strategies such as high dose sublingual or extended-release buprenorphine, or an app-based behavioral intervention improve retention on MOUD.

Clinicaltrials: gov Identifier: NCT04464980.

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