Optimizing retention strategies for opioid use disorder pharmacotherapy: The retention phase of the CTN-0100 trial (RDD)

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

doi:10.1016/j.cct.2025.107816

Optimizing retention strategies for opioid use disorder pharmacotherapy: The retention phase of the CTN-0100 trial (RDD)

Contemp Clin Trials. 2025 Mar:150:107816. doi: 10.1016/j.cct.2025.107816. Epub 2025 Jan 20.

Authors

Affiliations

¹ New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, USA; Columbia University Irving Medical Center, 630 West 168(th) St., New York, NY 10032, USA. Electronic address: matisyahu.shulman@nyspi.columbia.edu.
² New York University Grossman School of Medicine, 550 1(st) Ave., New York, NY 10016, USA. Electronic address: sarah.meyers-ohki@nyulangone.org.
³ New York University Grossman School of Medicine, 550 1(st) Ave., New York, NY 10016, USA. Electronic address: patricia.novo@nyulangone.org.
⁴ McLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA 02478, USA. Electronic address: sprovost@mclean.harvard.edu.
⁵ New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, USA; Columbia University Irving Medical Center, 630 West 168(th) St., New York, NY 10032, USA. Electronic address: kaitlyn.ohrtman@nyspi.columbia.edu.
⁶ The Emmes Company, LLC, 401 N Washington St., #700, Rockville, MD 20850, USA. Electronic address: pvanveldhuisen@emmes.com.
⁷ The Emmes Company, LLC, 401 N Washington St., #700, Rockville, MD 20850, USA. Electronic address: noden@emmes.com.
⁸ The Emmes Company, LLC, 401 N Washington St., #700, Rockville, MD 20850, USA. Electronic address: motterstatter@emmes.com.
⁹ Warren Alpert School of Medicine of Brown University / Stanley Street Treatment and Resources, Inc., 222 Richmond St., Providence, RI 02903, USA. Electronic address: genie_bailey@brown.edu.
¹⁰ National Institute on Drug Abuse, 11601 Landsdown St., North Bethesda, MD 20852, USA. Electronic address: dliu@nida.nih.gov.
¹¹ New York University Grossman School of Medicine, 550 1(st) Ave., New York, NY 10016, USA. Electronic address: john.rotrosen@nyulangone.org.
¹² McLean Hospital/Harvard Medical School, 115 Mill St., Belmont, MA 02478, USA. Electronic address: rweiss@mclean.harvard.edu.
¹³ New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, USA; Columbia University Irving Medical Center, 630 West 168(th) St., New York, NY 10032, USA. Electronic address: edward.nunes@nyspi.columbia.edu.

PMID: 39842691
PMCID: PMC11867840 (available on 2026-03-01)
DOI: 10.1016/j.cct.2025.107816

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.

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

Publication types

Clinical Trial Protocol

MeSH terms

Administration, Sublingual
Adult
Buprenorphine* / administration & dosage
Buprenorphine* / therapeutic use
Delayed-Action Preparations
Female
Humans
Male
Multicenter Studies as Topic
Naltrexone* / administration & dosage
Naltrexone* / therapeutic use
Narcotic Antagonists* / administration & dosage
Narcotic Antagonists* / therapeutic use
Opiate Substitution Treatment* / methods
Opioid-Related Disorders* / drug therapy
Patient Dropouts / statistics & numerical data
Randomized Controlled Trials as Topic

Optimizing retention strategies for opioid use disorder pharmacotherapy: The retention phase of the CTN-0100 trial (RDD)

Authors

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Abstract

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