Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)
NCT ID: NCT04464980
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
1516 participants
INTERVENTIONAL
2021-06-08
2027-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Retention: SL-BUP standard dose + 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.
SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
MM
MM consists of standard Medical Management and the usual counseling at the treatment program.
Retention: SL-BUP high dose + 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.
SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
MM
MM consists of standard Medical Management and the usual counseling at the treatment program.
Retention: XR-BUP + MM
Extended-release injectable buprenorphine (XR-BUP) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
MM
MM consists of standard Medical Management and the usual counseling at the treatment program.
Retention: XR-NTX + MM
Extended-release injectable naltrexone (XR-NTX) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
XR-NTX
Monthly dosing of extended-release injectable naltrexone
MM
MM consists of standard Medical Management and the usual counseling at the treatment program.
Retention: SL-BUP standard dose + 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.
SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
MMR
MMR consists of Medical Management and usual counseling, plus a technology-based behavioral component.
Retention: SL-BUP high dose + 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.
SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
MMR
MMR consists of Medical Management and usual counseling, plus a technology-based behavioral component.
Retention: XR-BUP + MMR
Extended-release injectable buprenorphine (XR-BUP) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
MMR
MMR consists of Medical Management and usual counseling, plus a technology-based behavioral component.
Retention: XR-NTX + MMR
Extended-release injectable naltrexone (XR-NTX) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
XR-NTX
Monthly dosing of extended-release injectable naltrexone
MMR
MMR consists of Medical Management and usual counseling, plus a technology-based behavioral component.
Discontinuation: Discontinue SL-BUP with SL-BUP + MM
Start on SL-BUP, taper with SL-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
MM
MM consists of standard Medical Management and the usual counseling at the treatment program.
Discontinuation: Discontinue SL-BUP with XR-BUP + MM
Start on SL-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
MM
MM consists of standard Medical Management and the usual counseling at the treatment program.
Discontinuation: Discontinue XR-BUP with XR-BUP + MM
Start on XR-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
MM
MM consists of standard Medical Management and the usual counseling at the treatment program.
Discontinuation: Discontinue XR-NTX with XR-NTX + MM
Start on XR-NTX, taper with XR-NTX, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
XR-NTX
Monthly dosing of extended-release injectable naltrexone
MM
MM consists of standard Medical Management and the usual counseling at the treatment program.
Discontinuation: Discontinue SL-BUP with SL-BUP + 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.
SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
MMD
MMD consists of Medical Management and usual counseling, plus a technology-based behavioral component.
Discontinuation: Discontinue SL-BUP with XR-BUP + 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.
XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
MMD
MMD consists of Medical Management and usual counseling, plus a technology-based behavioral component.
Discontinuation: Discontinue XR-BUP with XR-BUP + 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.
XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
MMD
MMD consists of Medical Management and usual counseling, plus a technology-based behavioral component.
Discontinuation: Discontinue XR-NTX with XR-NTX + 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.
XR-NTX
Monthly dosing of extended-release injectable naltrexone
MMD
MMD consists of Medical Management and usual counseling, plus a technology-based behavioral component.
Interventions
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SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
XR-NTX
Monthly dosing of extended-release injectable naltrexone
MM
MM consists of standard Medical Management and the usual counseling at the treatment program.
MMR
MMR consists of Medical Management and usual counseling, plus a technology-based behavioral component.
MMD
MMD consists of Medical Management and usual counseling, plus a technology-based behavioral component.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Meet DSM-5 criteria for current opioid use disorder (heroin, fentanyl or other synthetic opioids, and/or prescription opioids);
3. Seeking treatment for opioid use disorder and choosing either buprenorphine (BUP) or extended-release injection naltrexone (XR-NTX);
4. If choosing buprenorphine, willing to be randomized to SL-BUP-16mg, SL-BUP-32mg, or XR-BUP;
5. 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);
6. 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;
7. Willing and able to provide written informed consent;
8. Able to speak English sufficiently to understand the study procedures;
9. 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).
1. 18 years of age or older;
2. 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;
3. Express the desire to discontinue MOUD after a shared decision-making discussion with the treating provider;
4. Meet stability criteria, i.e., have abstained from opioids (other than buprenorphine), cocaine, methamphetamine, and non-prescribed benzodiazepines for the past ≥12 weeks, and do not meet DSM-5 criteria for current (≥12 weeks) alcohol use disorder (participants with cannabis use will be eligible);
5. If currently taking buprenorphine, are willing to take either SL-BUP or XR-BUP if randomized to that condition;
6. Willing to be randomized to either MM or to MMD;
7. Able to provide written informed consent after discussion with their provider regarding the risks of discontinuation;
8. Able to speak English sufficiently to understand the study procedures;
9. If female of childbearing potential, willing to practice an effective method of birth control while in the study and taking study medication (participants who become pregnant during the study will continue to be followed; treatment may be modified consistent with pregnancy).
Exclusion Criteria
1. 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;
2. 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);
3. Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use, requiring a different level of care (e.g., hospitalization);
2. Suicidal or homicidal ideation or behavior requiring a different level of care (e.g., hospitalization);
3. Known allergy or sensitivity to preferred medication or its components;
4. Maintenance on methadone at the time of signing consent;
5. For those preferring XR-NTX, presence of pain of sufficient severity as to require ongoing pain management with opioids;
6. 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);
7. If female, currently pregnant or breastfeeding or planning on conception;
8. 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;
9. Have used the reSET-O or CHESS Connections mHealth apps in the 3 months prior to consent;
10. Other major reasons that might prevent an individual from participating in the study (e.g., a planned move out of the area).
1. Serious medical or psychiatric disorder or concomitant medication that, in the opinion of the study medical clinician, would make study participation hazardous to the participant or compromise study findings or would prevent the participant from completing the study. Examples include:
1. 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;
2. 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);
2. Suicidal or homicidal ideation or behavior requiring a different level of care (e.g., hospitalization);
3. For participants entering the study taking buprenorphine, presence of pain requiring or likely requiring ongoing pain management with buprenorphine or other opioids;
4. If female, currently pregnant or breastfeeding or planning on conception;
5. Use of opioids (other than buprenorphine), cocaine, methamphetamine, or non-prescribed benzodiazepines in the past 12 weeks;
6. Meets current DSM-5 criteria for any current alcohol use disorder;
7. 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;
8. Have used the Connections mHealth app in the 3 months prior to consent (other than Connections in the Retention Phase);
9. Other major reasons that might prevent an individual from participating in the study (e.g., a planned move out of the area.
18 Years
ALL
No
Sponsors
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New York State Psychiatric Institute
OTHER
Columbia University
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
Mclean Hospital
OTHER
National Institute on Drug Abuse (NIDA)
NIH
The Emmes Company, LLC
INDUSTRY
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Edward V Nunes, MD
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute/Columbia University Irving Medical Center
John Rotrosen, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Roger Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School/McLean Hospital
Locations
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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
Roseburg, Oregon, 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
Countries
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References
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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.
Shulman 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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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CTN-0100
Identifier Type: OTHER
Identifier Source: secondary_id
20-PRS-057
Identifier Type: OTHER
Identifier Source: secondary_id
146193
Identifier Type: OTHER
Identifier Source: secondary_id
19-01363
Identifier Type: -
Identifier Source: org_study_id
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