Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)
NIDA-CTN-0100: Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)
6 other identifiers
interventional
1,516
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2021
Longer than P75 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2020
CompletedFirst Posted
Study publicly available on registry
July 9, 2020
CompletedStudy Start
First participant enrolled
June 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
October 1, 2026
July 1, 2026
5.6 years
June 29, 2020
September 30, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Retention: Continuous retention in MOUD treatment through 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 on MOUD over the 26-week period.
Retention: from randomization through 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.
Discontinuation: from randomization through week 24 follow up
Secondary Outcomes (7)
Retention KS1: Weekly opioid abstinence
Retention: from randomization through week 26
Retention KS2: Treatment effectiveness
Retention: at week 26
Retention KS3: Treatment by baseline severity
Retention: at week 26
Discontinuation KS1: Completed Discontinuation
Discontinuation: from randomization through week 24 follow up
Discontinuation KS2: Relapse
Discontinuation: from randomization through week 24 follow up
- +2 more secondary outcomes
Study Arms (16)
Retention: SL-BUP standard dose + MM
EXPERIMENTALStandard 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
EXPERIMENTALHigh 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-BUP + MM
EXPERIMENTALExtended-release injectable buprenorphine (XR-BUP) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Retention: XR-NTX + MM
EXPERIMENTALExtended-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
EXPERIMENTALStandard 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
EXPERIMENTALHigh 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
EXPERIMENTALExtended-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
EXPERIMENTALExtended-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
EXPERIMENTALStart 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
EXPERIMENTALStart 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
EXPERIMENTALStart 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
EXPERIMENTALStart 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
EXPERIMENTALStart 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
EXPERIMENTALStart 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
EXPERIMENTALStart 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
EXPERIMENTALStart on XR-NTX, taper with XR-NTX, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Interventions
Weekly/monthly dosing of extended-release injectable buprenorphine
Monthly dosing of extended-release injectable naltrexone
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.
Daily dosing of sublingual buprenorphine-naloxone
MM consists of standard Medical Management and the usual counseling at the treatment program.
Eligibility Criteria
You may qualify if:
- years of age or older;
- Meet DSM-5 criteria for current opioid use disorder (heroin, fentanyl or other synthetic opioids, and/or prescription opioids);
- Seeking treatment for opioid use disorder and choosing either buprenorphine (BUP) or extended-release injection naltrexone (XR-NTX);
- If choosing buprenorphine, willing to be randomized to SL-BUP-16mg, SL-BUP-32mg, or XR-BUP;
- Willing to be randomized to either MM (standard Medical Management plus counseling treatment as usual available at the site) or MMR (MM plus usual counseling and access to an app delivering CM + CBT);
- In good-enough general health (meaning good enough health to be in outpatient treatment) as determined by the study medical clinician on the basis of medical history, review of systems, and physical/mental status exam, to permit treatment with XR-NTX or BUP;
- Willing and able to provide written informed consent;
- Able to speak English sufficiently to understand the study procedures;
- If female of childbearing potential, willing to practice an effective method of birth control for the duration of participation in the study (participants who become pregnant during the study will continue to be followed; treatment may be modified consistent with pregnancy).
You may not qualify if:
- Serious medical, psychiatric, or co-occurring substance use disorder or concomitant medication that, in the opinion of the study medical clinician, makes the patient not appropriate for outpatient treatment with buprenorphine or XR-NTX, but instead requires a higher or different level of care. Examples include:
- Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;
- Severe, untreated or inadequately treated psychiatric condition (e.g., active psychosis, uncontrolled bipolar disorder) as assessed by history and/or clinical interview, requiring a different level of care (e.g., hospitalization);
- Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use, requiring a different level of care (e.g., hospitalization);
- Suicidal or homicidal ideation or behavior requiring a different level of care (e.g., hospitalization);
- Known allergy or sensitivity to preferred medication or its components;
- Maintenance on methadone at the time of signing consent;
- For those preferring XR-NTX, presence of pain of sufficient severity as to require ongoing pain management with opioids;
- For those preferring XR-NTX, body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX (e.g., BMI\>40, excess fat tissue over the buttocks, emaciation);
- If female, currently pregnant or breastfeeding or planning on conception;
- Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities;
- Have used the reSET-O or CHESS Connections mHealth apps in the 3 months prior to consent;
- Other major reasons that might prevent an individual from participating in the study (e.g., a planned move out of the area).
- years of age or older;
- Have been receiving buprenorphine for OUD for at least the past year or XR-NTX pharmacotherapy for OUD for at least the past 6 months prior to consent for the Discontinuation Phase;
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitycollaborator
- Harvard Medical School (HMS and HSDM)collaborator
- National Institute on Drug Abuse (NIDA)collaborator
- Mclean Hospitalcollaborator
- NYU Langone Healthlead
- New York State Psychiatric Institutecollaborator
- The Emmes Company, LLCcollaborator
Study Sites (21)
University of Arkansas for Medical Sciences (UAMS) / Center for Addiction Services and Treatment (CAST)
Little Rock, Arkansas, 72205, United States
Tarzana Treatment Centers, Inc.
Tarzana, California, 91356, United States
Liberation Programs, Inc.
Bridgeport, Connecticut, 06610, United States
Operation PAR
Clearwater, Florida, 33760, United States
Gateway Community Services
Jacksonville, Florida, 32204, United States
Aspire Health Partners
Orlando, Florida, 32806, United States
Mountain Manor / Maryland Treatment Centers
Baltimore, Maryland, 21229, United States
McLean Hospital
Belmont, Massachusetts, 02478, United States
Stanley Street Treatment and Resources, Inc.
Fall River, Massachusetts, 02720, United States
Square Medical Group, LLC
Newton, Massachusetts, 02458, United States
Gibson Center for Behavioral Change
Cape Girardeau, Missouri, 63703, United States
Dartmouth Hitchcock - ATP
Lebanon, New Hampshire, 03766, United States
University of New Mexico Addiction and Substance Abuse Program
Albuquerque, New Mexico, 87106, United States
Bellevue Hospital Center
New York, New York, 10016, United States
Adapt Integrated Health Care
Roseburg, Oregon, 97470, United States
Adapt Integrated Health Care
Winston, Oregon, 97496, United States
Center for Psychiatric and Chemical Dependency Services (CPCDS)
Pittsburgh, Pennsylvania, 15213, United States
Internal Medicine Recovery Engagement Program (IM-REP)
Pittsburgh, Pennsylvania, 15219, United States
Shoreline Behavioral Health Services
Conway, South Carolina, 29526, United States
Huntsman Mental Health Institute / University of Utah
Salt Lake City, Utah, 84108, United States
Chestnut Ridge Center
Morgantown, West Virginia, 26505, United States
Related Publications (2)
Shulman M, Meyers-Ohki S, Novo P, Provost S, Ohrtman K, Van Veldhuisen P, Oden N, Otterstatter M, Bailey GL, Liu D, Rotrosen J, Weiss RD, Nunes EV. Optimizing retention strategies for opioid use disorder pharmacotherapy: The retention phase of the CTN-0100 trial (RDD). Contemp Clin Trials. 2025 Mar;150:107816. doi: 10.1016/j.cct.2025.107816. Epub 2025 Jan 20.
PMID: 39842691DERIVEDShulman M, Provost S, Ohrtman K, Novo P, Meyers-Ohki S, Van Veldhuisen P, Oden N, Otterstatter M, Bailey GL, Liu D, Rotrosen J, Nunes EV, Weiss RD. Discontinuation of medication treatment for opioid use disorder after a successful course: The discontinuation phase of the CTN-0100 (RDD) trial. Contemp Clin Trials. 2024 Jul;142:107543. doi: 10.1016/j.cct.2024.107543. Epub 2024 Apr 23.
PMID: 38657730DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward V Nunes, MD
New York State Psychiatric Institute/Columbia University Irving Medical Center
- PRINCIPAL INVESTIGATOR
John Rotrosen, MD
NYU Langone Health
- PRINCIPAL INVESTIGATOR
Roger Weiss, MD
Harvard Medical School/McLean Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2020
First Posted
July 9, 2020
Study Start
June 8, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
October 1, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
This study will comply with the NIH Data Sharing Policy and Implementation Guidance (https://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm) and (for HEAL-funded studies) the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy). Primary data for this study will be available to the public in the NIDA data repository. For more details on data sharing please visit https://datashare.nida.nih.gov/. The primary outcome(s) publication will be included along with study underlying primary data in the data share repository, and it will also be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/).