Site for Site for CTN-0100: Optimizing Retention Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

Brief description of study

The main aims are: 1. To test, among patients seeking treatment for opioid use disorder (OUD), strategies to improve retention in treatment on medications for opioid use disorder (MOUD). 2. To test strategies to improve outcomes among patients who have achieved stable remission on MOUD and want to discontinue MOUD. 3. To develop predictive models of successful discontinuation of MOUD among patients who discontinue medication, based on patient characteristics, including duration of MOUD prior to discontinuation. The study will have a multicenter, randomized, pragmatic non-blinded design, and incorporate two phases: In the Retention Phase, patients seeking treatment for OUD will enter the study as part of intake into standard-of-care MOUD treatment. They will choose between MOUD with buprenorphine (BUP) or extended-release naltrexone (XR-NTX). Participants choosing MOUD with BUP will be randomly assigned in a 3 by 2 factorial design with 3 pharmacological conditions (standard dose sublingual BUP (SL-BUP); high dose SL-BUP; or extended-release injection BUP (XR-BUP)) crossed with 2 behavioral conditions (Medical Management and usual counseling (MM) or MM plus a technology-based behavioral component (MMR)). Participants choosing MOUD with XR-NTX will only be randomized to one of the 2 behavioral interventions (MM or MMR). Participants are eligible to receive their assigned study MOUD for 72 weeks following randomization and will be followed for an additional 24 weeks, for a total of 96 weeks post-randomization. In the Discontinuation Phase, participants will not be actively recruited; instead, stable patients seeking to discontinue MOUD will be referred to the study (either from the participating site's existing caseload or from the Retention Phase). Participants must meet study-defined stability and abstinence criteria as part of eligibility. Eligible participants who enter the study on SL-BUP will be randomly assigned in a 2 by 2 factorial design with 2 pharmacological conditions (standard taper using SL-BUP or taper with XR-BUP) crossed with 2 behavioral conditions (MM or MM plus a technology-based behavioral component (MMD)). Participants entering the Discontinuation Phase on XR-BUP or XR-NTX will only be randomized to one of the 2 behavioral interventions (MM or MMD). Participants have up to 48 weeks to complete their medication taper. Upon completion of taper (or following the end of the taper period, whichever comes first), all participants will enter a follow-up period lasting 24 weeks (and up to 72 weeks, if the overall study timeline allows). BUP participants may receive up to 6 injections of XR-NTX during the follow-up period.


Clinical Study Identifier: s20-00773
Principal Investigator: Mathew B. Kladney.


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