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)

PHASE3CompletedINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

October 27, 2016

Study Completion Date

January 9, 2017

Conditions
Opioid Use Disorder
Interventions
DRUG

NTX/BUP

Daily doses

DRUG

NTX/PBO-B

Daily doses

DRUG

PBO-N/PBO-B

Daily doses

Trial Locations (20)

10032

New York State Psychiatric Institute/ Columbia University, New York

15213

Western Psychiatric Institute and Clinic of UPMC, Pittsburgh

19104

University Of Pennsylvania - Treatment Research Center, Philadelphia

21224

John Hopkins University School of Medicine, Baltimore

27705

Duke University Medical Center, Durham

32751

Pharmaceutical Research Associates Inc., Salt Lake City

32801

CNS Healthcare, Orlando

33308

Atlantic Shores Hospital, Lauderhill

33334

Research Centers of America, Oakland Park

44718

Neuro-Behavioral Clinical Research, Inc., Canton

45417

Midwest Clinical Research Center, LLC, Dayton

60190

Neuroscience Research Institute, Winfield

75115

Insite Clinical Research, DeSoto

77030

Baylor College of Medicine, Houston

78754

Community Clinical Research, Inc., Austin

84107

TRY Research, Maitland

92056

North Country Clinical Research, Oceanside

92868

NRC Research Institute, Orange

08009

Comprehensive Clinical Research, Berlin

08053

PRA Health Sciences, Marlton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alkermes, Inc.

INDUSTRY