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Completed Phase 3 Interventional Results available

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)

ClinicalTrials.gov ID: NCT02537574

Public ClinicalTrials.gov record NCT02537574. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 10:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL®

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02537574
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Alkermes, Inc.
Industry
Enrollment
380 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 60 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2015 (Actual)
Primary completion
Oct 27, 2016 (Actual)
Completion
Jan 9, 2017 (Actual)
Last update posted
Mar 6, 2019

2015 – 2017

United States locations

U.S. sites
20
U.S. states
11
U.S. cities
20
Facility City State ZIP Site status
North Country Clinical Research Oceanside California 92056 —
NRC Research Institute Orange California 92868 —
Atlantic Shores Hospital Lauderhill Florida 33308 —
TRY Research Maitland Florida 84107 —
Research Centers of America Oakland Park Florida 33334 —
CNS Healthcare Orlando Florida 32801 —
Neuroscience Research Institute Winfield Illinois 60190 —
John Hopkins University School of Medicine Baltimore Maryland 21224 —
Comprehensive Clinical Research Berlin New Jersey 08009 —
PRA Health Sciences Marlton New Jersey 08053 —
New York State Psychiatric Institute/ Columbia University New York New York 10032 —
Duke University Medical Center Durham North Carolina 27705 —
Neuro-Behavioral Clinical Research, Inc. Canton Ohio 44718 —
Midwest Clinical Research Center, LLC Dayton Ohio 45417 —
University Of Pennsylvania - Treatment Research Center Philadelphia Pennsylvania 19104 —
Western Psychiatric Institute and Clinic of UPMC Pittsburgh Pennsylvania 15213 —
Community Clinical Research, Inc. Austin Texas 78754 —
Insite Clinical Research DeSoto Texas 75115 —
Baylor College of Medicine Houston Texas 77030 —
Pharmaceutical Research Associates Inc. Salt Lake City Utah 32751 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02537574, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 6, 2019 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02537574 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →