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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 Jul 21, 2026, 4:46 PM 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®

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

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

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
Jul 31, 2015
Primary completion
Oct 26, 2016
Completion
Jan 8, 2017
Last update posted
Mar 5, 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 5, 2019 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02537574 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →