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NCT05011266 · ClinicalTrials.gov registry record · Phase 2

Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder

A Phase 2 study of Opioid Use Disorder, sponsored by New York State Psychiatric Institute.

Recruiting
Registry status
Phase 2
Development phase
180
Enrollment target
2
Study locations

NCT05011266 is a Phase 2 study of Opioid Use Disorder that is actively recruiting participants, run by New York State Psychiatric Institute. The registered enrollment target is 180 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT05011266, a Phase 2 study of Opioid Use Disorder, is actively recruiting participants, sponsored by New York State Psychiatric Institute.

RECRUITING
Registry status
Phase 2
Development phase
180 participants
Enrollment target
2
Study locations

Study Summary

This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled study to examine whether addition of buprenorphine-naloxone will improve treatment retention, reduce opioid craving, and improve mood over 24 weeks of treatment with extended release naltrexone (XR-naltrexone) administered every four weeks for a total of 6 injections. The NYSPI site, which provides study oversight (no direct participant involvement) is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.

Conditions Studied

Opioid Use Disorder

Interventions

  • DRUG Placebo
  • DRUG Buprenorphine/naloxone

Study Locations (2)

Maryland

  • Avery Road Treatment Center (ARTC) - Rockville

New York

  • Stars/Nyspi - New York

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2023-04-18
Est. Completion 2026-06-01
Phase Phase 2

Sponsor

New York State Psychiatric Institute

364 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05011266

The ClinicalTrials.gov registry entry for NCT05011266 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (96% lower). The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05011266 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, New York.

Frequently Asked Questions

What is clinical trial NCT05011266 about?

NCT05011266 is a clinical study titled "Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder". This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled st...

What is the current status of trial NCT05011266?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2023-04-18. Estimated completion is 2026-06-01.

What conditions does trial NCT05011266 study?

This clinical trial studies the following conditions: Opioid Use Disorder.

What interventions are being tested in trial NCT05011266?

The interventions under investigation include: Placebo (DRUG), Buprenorphine/naloxone (DRUG).

Who is sponsoring clinical trial NCT05011266?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05011266 being conducted?

This trial has 2 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.