Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)
- Conditions
- Opioid Use Disorder (OUD)
- Interventions
- Registration Number
- NCT04464980
- Lead Sponsor
- NYU Langone Health
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2190
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Retention: SL-BUP standard dose + MM SL-BUP Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Retention: SL-BUP standard dose + MM MM Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Retention: SL-BUP high dose + MM SL-BUP High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Retention: SL-BUP high dose + MM MM High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Retention: XR-NTX + MM MM Extended-release injectable naltrexone (XR-NTX) plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Retention: XR-BUP + MM XR-BUP Extended-release injectable buprenorphine (XR-BUP) plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Retention: XR-BUP + MM MM Extended-release injectable buprenorphine (XR-BUP) plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Retention: XR-NTX + MM XR-NTX Extended-release injectable naltrexone (XR-NTX) plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Retention: SL-BUP standard dose + MMR SL-BUP Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MMR, consisting of Medical Management and usual counseling, plus a technology-based behavioral component. Retention: SL-BUP standard dose + MMR MMR Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MMR, consisting of Medical Management and usual counseling, plus a technology-based behavioral component. Retention: SL-BUP high dose + MMR SL-BUP High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Retention: SL-BUP high dose + MMR MMR High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Retention: XR-BUP + MMR XR-BUP Extended-release injectable buprenorphine (XR-BUP) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Retention: XR-BUP + MMR MMR Extended-release injectable buprenorphine (XR-BUP) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Retention: XR-NTX + MMR XR-NTX Extended-release injectable naltrexone (XR-NTX) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Retention: XR-NTX + MMR MMR Extended-release injectable naltrexone (XR-NTX) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Discontinuation: Discontinue SL-BUP with SL-BUP + MM SL-BUP Start on SL-BUP, taper with SL-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Discontinuation: Discontinue SL-BUP with SL-BUP + MM MM Start on SL-BUP, taper with SL-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Discontinuation: Discontinue SL-BUP with XR-BUP + MM XR-BUP Start on SL-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Discontinuation: Discontinue SL-BUP with XR-BUP + MM MM Start on SL-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Discontinuation: Discontinue XR-BUP with XR-BUP + MM XR-BUP Start on XR-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Discontinuation: Discontinue XR-BUP with XR-BUP + MM MM Start on XR-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Discontinuation: Discontinue XR-NTX with XR-NTX + MM XR-NTX Start on XR-NTX, taper with XR-NTX, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Discontinuation: Discontinue XR-NTX with XR-NTX + MM MM Start on XR-NTX, taper with XR-NTX, plus MM, consisting of standard Medical Management and usual counseling at the treatment program. Discontinuation: Discontinue SL-BUP with SL-BUP + MMD SL-BUP Start on SL-BUP, taper with SL-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Discontinuation: Discontinue SL-BUP with SL-BUP + MMD MMD Start on SL-BUP, taper with SL-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Discontinuation: Discontinue SL-BUP with XR-BUP + MMD XR-BUP Start on SL-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Discontinuation: Discontinue SL-BUP with XR-BUP + MMD MMD Start on SL-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Discontinuation: Discontinue XR-BUP with XR-BUP + MMD XR-BUP Start on XR-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Discontinuation: Discontinue XR-BUP with XR-BUP + MMD MMD Start on XR-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Discontinuation: Discontinue XR-NTX with XR-NTX + MMD XR-NTX Start on XR-NTX, taper with XR-NTX, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component. Discontinuation: Discontinue XR-NTX with XR-NTX + MMD MMD Start on XR-NTX, taper with XR-NTX, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
- Primary Outcome Measures
Name Time Method Retention: Continuous retention in MOUD treatment at 26 weeks Retention: at week 26 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.
Discontinuation: Completed Discontinuation without Relapse Discontinuation: at week 24 follow up 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.
- Secondary Outcome Measures
Name Time Method DSK2: Treatment effectiveness Discontinuation: week 24 follow up 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).
Retention KS1: Weekly opioid abstinence Retention: through week 26 Weekly opioid abstinence (measured by Timeline Followback, not contradicted by toxicology test). Repeated yes/no measure for each of weeks 3 through 26.
Retention KS2: Treatment effectiveness Retention: at week 26 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.
Discontinuation KS1: Other discontinuation outcomes Discontinuation: at week 24 follow up 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).
Trial Locations
- Locations (20)
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
Gibson Center for Behavioral Change
🇺🇸Cape Girardeau, Missouri, United States
Dartmouth Hitchcock - ATP
🇺🇸Lebanon, New Hampshire, United States
University of New Mexico Addiction and Substance Abuse Program
🇺🇸Albuquerque, New Mexico, United States
Bellevue Hospital Center
🇺🇸New York, New York, United States
Adapt Integrated Health Care
🇺🇸Winston, Oregon, United States
Center for Psychiatric and Chemical Dependency Services (CPCDS)
🇺🇸Pittsburgh, Pennsylvania, United States
Internal Medicine Recovery Engagement Program (IM-REP)
🇺🇸Pittsburgh, Pennsylvania, United States
Shoreline Behavioral Health Services
🇺🇸Conway, South Carolina, United States
Huntsman Mental Health Institute / University of Utah
🇺🇸Salt Lake City, Utah, United States
Chestnut Ridge Center
🇺🇸Morgantown, West Virginia, United States