A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction

PHASE3CompletedINTERVENTIONAL
Enrollment

287

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Opioid Dependency
Interventions
DRUG

Probuphine (buprenorphine implant)

Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.

DRUG

placebo implant

Implant contains ethylene vinyl acetate

DRUG

Buprenorphine

sublingual buprenorphine/naloxone tablets

Trial Locations (20)

10010

New York VA Medical Center, NYU School of Medicine, New York

10025

St. Luke's Roosevelt Hospital Center, New York

19104

University of Pennsylvania, Philadelphia

21224

BPRU, Behavioral Biology Research Center, Baltimore

27705

Duke University, Duke Addictions Program, Durham

29407

Carolina Clinical Trials, Inc., Charleston

32256

Amit Vijapura, MD, Jacksonville

33161

Scientific Clinical Research, Inc., North Miami

33319

Fidelity Clinical Research, Inc., Lauderhill

33771

Operation PAR, Inc. - TC Campus, Largo

39232

Precise Research Centers, Flowood

45220

University of Cincinnati, Cincinnati

63128

PsychCare Consultants Research, St Louis

90025

David Geffen School of Medicine at UCLA, Los Angeles

90502

Friends Research Institute, Torrance

91950

Synergy Clinical Research Center, National City

92056

North County Clinical Research, Oceanside

98201

Providence Behavioral Health Services, Everett

02720-6009

SSTAR: Stanley Street Treatment and Resources, Inc., Fall River

05401

University of Vermont, Burlington

Sponsors
All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Titan Pharmaceuticals

INDUSTRY