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NCT04464980 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Opioid Use Disorder (OUD), sponsored by NYU Langone Health.

Active
Registry status
Phase 2
Development phase
1,516
Enrollment target
20
Study locations

NCT04464980: Active Phase 2 study of Opioid Use Disorder (OUD), sponsored by NYU Langone Health.

NCT04464980 is a Phase 2 study of Opioid Use Disorder (OUD) that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 1,516 participants, above the 101-participant average among 7 other Opioid Use Disorder (OUD) trials with a reported enrollment target (1401% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04464980, a Phase 2 study of Opioid Use Disorder (OUD), is active but no longer recruiting, sponsored by NYU Langone Health.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
1,516 participants
Enrollment target
20
Study locations

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.

Primary Outcome

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.

Conditions Studied

Opioid Use Disorder (OUD)

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
NYU Langone Health

1,164 total trials

What the registry record for NCT04464980 still lists

NCT04464980 is an interventional study that assigns participants to a tested intervention. Its 1,516 participants enrollment target places it among the larger protocols in the corpus, above the 101-participant average among 7 other Opioid Use Disorder (OUD) trials with a reported enrollment target (1401% higher).

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.

NCT04464980 names 20 study sites across 14 states, led by Florida, Massachusetts, Oregon.

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).

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).

Who is sponsoring clinical trial NCT04464980?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

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.

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Related registry views

Source: ClinicalTrials.gov NCT04464980, the US trial registry maintained by the National Library of Medicine. NCT04464980 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.