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

Jan-25

Journal Article

Authors:

Shulman, M.

Meyers-Ohki, S.

Novo, P.

Provost, S.

Ohrtman, K.

Van Veldhuisen, P.

Oden, N.

Otterstatter, M.

Bailey, G. L.

Liu, D.

Rotrosen, J.

Weiss, R. D.

Nunes, E. V.

Pagination:
107816

Journal:
Contemp Clin Trials

PMID:
39842691

URL:
https://www.ncbi.nlm.nih.gov/pubmed/39842691

DOI:
10.1016/j.cct.2025.107816

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

Abstract:
<p>NTRODUCTION 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 x 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.</p>

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