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NCT02537574 · ClinicalTrials.gov registry record · Phase 3

Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)

A Phase 3 study of Opioid Use Disorder, sponsored by Alkermes.

Completed
Registry status
Phase 3
Development phase
380
Enrollment target
20
Study locations

NCT02537574 is a Phase 3 study of Opioid Use Disorder that has completed, run by Alkermes. The registered enrollment target is 380 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT02537574, a Phase 3 study of Opioid Use Disorder, has completed, sponsored by Alkermes.

COMPLETED
Registry status
Phase 3
Development phase
380 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.

Conditions Studied

Opioid Use Disorder

Interventions

  • DRUG NTX/BUP
  • DRUG NTX/PBO-B
  • DRUG PBO-N/PBO-B

Study Locations (20)

Florida

  • Atlantic Shores Hospital - Lauderhill
  • TRY Research - Maitland
  • Research Centers of America - Oakland Park
  • CNS Healthcare - Orlando

Texas

  • Community Clinical Research, Inc. - Austin
  • Insite Clinical Research - DeSoto
  • Baylor College of Medicine - Houston

California

  • North Country Clinical Research - Oceanside
  • NRC Research Institute - Orange

New Jersey

  • Comprehensive Clinical Research - Berlin
  • PRA Health Sciences - Marlton

Ohio

  • Neuro-Behavioral Clinical Research, Inc. - Canton
  • Midwest Clinical Research Center, LLC - Dayton

Pennsylvania

  • University Of Pennsylvania - Treatment Research Center - Philadelphia
  • Western Psychiatric Institute and Clinic of UPMC - Pittsburgh

Illinois

  • Neuroscience Research Institute - Winfield

Maryland

  • John Hopkins University School of Medicine - Baltimore

Trial Details

FieldValue
Enrollment Target 380 participants
Start Date 2015-08
Est. Completion 2017-01-09
Phase Phase 3

Sponsor

Alkermes

66 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02537574

The ClinicalTrials.gov registry entry for NCT02537574 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (92% lower). The listed sponsor is Alkermes, which has 66 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 3 interventions - of which NTX/BUP is the first listed.

NCT02537574 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Texas, California.

Frequently Asked Questions

What is clinical trial NCT02537574 about?

NCT02537574 is a clinical study titled "Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)". This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.

What is the current status of trial NCT02537574?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2015-08. Estimated completion is 2017-01-09.

What conditions does trial NCT02537574 study?

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

What interventions are being tested in trial NCT02537574?

The interventions under investigation include: NTX/BUP (DRUG), NTX/PBO-B (DRUG), PBO-N/PBO-B (DRUG).

Who is sponsoring clinical trial NCT02537574?

This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02537574 being conducted?

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

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

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.