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ACTIVE NOT RECRUITING Phase 2

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

NCT04464980 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG XR-NTX
  • DRUG SL-BUP
  • DRUG XR-BUP
  • BEHAVIORAL MM
  • BEHAVIORAL MMR

Study Locations (20)

Florida

  • Operation PAR — Clearwater
  • Gateway Community Services — Jacksonville
  • Aspire Health Partners — Orlando

Massachusetts

  • McLean Hospital — Belmont
  • Stanley Street Treatment and Resources, Inc. — Fall River
  • Square Medical Group, LLC — Newton

Oregon

  • Adapt Integrated Health Care — Roseburg
  • Adapt Integrated Health Care — Winston

Pennsylvania

  • Center for Psychiatric and Chemical Dependency Services (CPCDS) — Pittsburgh
  • Internal Medicine Recovery Engagement Program (IM-REP) — Pittsburgh

Arkansas

  • University of Arkansas for Medical Sciences (UAMS) / Center for Addiction Services and Treatment (CAST) — Little Rock

California

  • Tarzana Treatment Centers, Inc. — Tarzana

Connecticut

  • Liberation Programs, Inc. — Bridgeport

Maryland

  • Mountain Manor / Maryland Treatment Centers — Baltimore

Trial Details

FieldValue
Enrollment Target 1,516 participants
Start Date 2021-06-08
Est. Completion 2027-01-31
Phase Phase 2

Sponsor

NYU Langone Health

1,204 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04464980

The ClinicalTrials.gov registry entry for NCT04464980 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,516 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Opioid Use Disorder (OUD) appearing as the primary indexed condition, and to 5 interventions — of which XR-NTX is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04464980 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, Massachusetts, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04464980 about?

NCT04464980 is a clinical study titled "Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)". 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). ...

What is the current status of trial NCT04464980?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 1,516 participants. The study started on 2021-06-08. Estimated completion is 2027-01-31.

What conditions does trial NCT04464980 study?

This clinical trial studies the following conditions: Opioid Use Disorder (OUD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04464980?

The interventions under investigation include: XR-NTX (DRUG), SL-BUP (DRUG), XR-BUP (DRUG), MM (BEHAVIORAL), MMR (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04464980?

This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04464980 being conducted?

This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial