This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.
The main objectives of this study are: 1. To test strategies to improve retention in treatment on medications for opioid use disorder (MOUD), among patients initiating treatment for OUD. 2. To test strategies to improve outcomes among patients who have achieved stable remission on MOUD and want to discontinue MOUD. 3. To develop models to predict who is able to discontinue MOUD without relapse, based on patient characteristics, including duration of MOUD prior to discontinuation. The study will have a multicenter, randomized, pragmatic non-blinded design. The study has two phases, a Retention Phase and a Discontinuation Phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,516
Daily dosing of sublingual buprenorphine-naloxone
Weekly/monthly dosing of extended-release injectable buprenorphine
Monthly dosing of extended-release injectable naltrexone
MM consists of standard Medical Management and the usual counseling at the treatment program.
MMR consists of Medical Management and usual counseling, plus a technology-based behavioral component.
MMD consists of Medical Management and usual counseling, plus a technology-based behavioral component.
University of Arkansas for Medical Sciences (UAMS) / Center for Addiction Services and Treatment (CAST)
Little Rock, Arkansas, United States
Tarzana Treatment Centers, Inc.
Tarzana, California, United States
Liberation Programs, Inc.
Bridgeport, Connecticut, United States
Operation PAR
Clearwater, Florida, United States
Gateway Community Services
Jacksonville, Florida, United States
Aspire Health Partners
Orlando, Florida, United States
Mountain Manor / Maryland Treatment Centers
Baltimore, Maryland, United States
McLean Hospital
Belmont, Massachusetts, United States
Stanley Street Treatment and Resources, Inc.
Fall River, Massachusetts, United States
Square Medical Group, LLC
Newton, Massachusetts, United States
...and 11 more locations
Retention: Continuous retention in MOUD treatment at 26 weeks
Binary (yes/no). Continuously enrolled in maintenance treatment on one or more of the evidence-based MOUD modalities (e.g., SL-BUP, XR-BUP, XR-NTX, or methadone maintenance) with no more than a 28-day gap in MOUD over the 26-week period.
Time frame: Retention: at week 26
Discontinuation: Completed Discontinuation without Relapse
Binary (yes/no). Discontinuing MOUD during the taper period, no return to MOUD, and no relapse to opioid use, either during the taper (up to 48 weeks for those entering on BUP or 24 weeks for those entering on XR-NTX) or during the 24 weeks after MOUD is discontinued.
Time frame: Discontinuation: at week 24 follow up
Retention KS1: Weekly opioid abstinence
Weekly opioid abstinence (measured by Timeline Followback, not contradicted by toxicology test). Repeated yes/no measure for each of weeks 3 through 26.
Time frame: Retention: through week 26
Retention KS2: Treatment effectiveness
Retention treatment effectiveness, measured by the Treatment Effectiveness Assessment (TEA, Ling et. al, 2012); a brief instrument to assess patient progress in treatment and recovery along 4 domains (substance use, health, lifestyle and community) at week 26.
Time frame: Retention: at week 26
Discontinuation KS1: Other discontinuation outcomes
Participants who did not meet the criteria for the primary outcome (Completed Discontinuation without Relapse), will be subcategorized into 3 other outcome categories: 1) Did not Complete Discontinuation (i.e., MOUD is continued or discontinued and then restarted within the next 24 weeks) and did not Relapse; 2) Completed Discontinuation followed by Relapse; or 3) Did not Complete Discontinuation and Relapse (i.e., relapse while on MOUD).
Time frame: Discontinuation: at week 24 follow up
DSK2: Treatment effectiveness
Discontinuation treatment effectiveness, measured by the Treatment Effectiveness Assessment (TEA, Ling et. al, 2012); a brief instrument to assess patient progress in treatment and recovery along 4 domains (substance use, health, lifestyle and community) at week 24. Measured at the end of taper (EOT): up to 24 weeks for tapers with XR-NTX and up to 48 weeks for tapers with BUP; and at the week 24 follow up (primary outcome timepoint).
Time frame: Discontinuation: week 24 follow up
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