Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) – A new research study through the NIDA Clinical Trials Network (CTN)

Scott E. Provost, MM, MSW

McLean Hospital
Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) – A new research study through the NIDA Clinical Trials Network (CTN)

Scientific Abstract

BACKGROUND AND AIMS: The New England Consortium Node, part of the NIDA Clinical Trials Network, is leading a pivotal study in collaboration with the NYU School of Medicine, and CTN Coordinating Centers. The study will be conducted at 18 sites nationwide and 2 Massachusetts sites: Square Medical Group and Stanley Street Treatment and Resources, Inc. The aims are to: 1) test strategies to improve retention in medication for opioid use disorder (MOUD); 2) test strategies to improve outcomes among patients who have achieved stable opioid abstinence and want to discontinue MOUD; and 3) develop models to predict who is able to discontinue MOUD safely without relapse.

STUDY DESIGN: The design is multicenter, randomized, pragmatic and non-blinded with a Retention and Discontinuation Phase. Up to 1630 participants in Retention and 1000 in Discontinuation will be randomized. Participants in Retention will be adults ≥18 years old seeking MOUD appropriate for buprenorphine (BUP) [N = 1,200] or extended-release naltrexone (XR-NTX) [N = 430]. Participants taking SL-BUP in Discontinuation will be randomized to a slow taper of SL-BUP [N = 500] or switch to XR-BUP [N = 250]. Participants in Discontinuation must have ≥1 year of BUP or 6 months of XR-NTX treatment, be stable (no opioid, cocaine, methamphetamine or non-prescribed benzodiazepine use and no diagnosed alcohol use disorder for ≥12 weeks), and express a desire to stop MOUD. In both phases, participants will also be randomized to standard Medical Management (MM) alone, or MM plus an app-based behavioral treatment: the Pear-OO2a app in Retention, which delivers Cognitive- Behavioral Counseling and Contingency Management; or the Connections app in Discontinuation, which offers a menu of features to support recovery.

HYPOTHESES: In Retention, better outcomes are anticipated with: 1) a high SL-BUP dose (target 32 mg/day) and XR-BUP than with the standard SL-BUP dose (target 16 mg/day); and 2) MM + Pear-OO2a than with MM alone. In Discontinuation, better outcomes are predicted with 1) a transition from SL-BUP to XR-BUP, which self-tapers, compared with the standard SL- BUP taper; and 2) MM + Connections than with MM alone.

Live Zoom Session – April 21st

research Areas

Authors

Scott E. Provost, MM, MSW, Chloe J. Jordan, PhD, Hannah Shapiro, BA, Catherine D. Trinh, BA, Andrew Peckham, PhD, Jungjin Kim, MD, Marc Copersino, PhD, Roger D. Weiss, MD

Principal Investigator

Roger D. Weiss, MD