Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED 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)

NCT02537574 · View on ClinicalTrials.gov ↗

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

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

19 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. It is categorized as Phase 3, 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 380 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkermes, which has 19 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 appearing as the primary indexed condition, and to 3 interventions — of which NTX/BUP 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: NCT02537574 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Texas, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02537574?

This trial is sponsored by Alkermes, which has 19 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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