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Completed Phase 3 Interventional

Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

ClinicalTrials.gov ID: NCT00447564

Public ClinicalTrials.gov record NCT00447564. 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 21, 2026, 1:24 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 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence

Brief summary

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

Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patients with opioid dependence.

Study identification

NCT ID
NCT00447564
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Titan Pharmaceuticals
Industry
Enrollment
163 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 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
Oct 2006 (Type not available)
Primary completion
Jul 2008 (Actual)
Completion
Jul 2008 (Actual)
Last update posted
Dec 31, 2018

2006 – 2008

United States locations

U.S. sites
18
U.S. states
12
U.S. cities
17
Facility City State ZIP Site status
David Geffen School of Medicine at UCLA Los Angeles California 90025 —
Synergy Clinical Research Center National City California 91950 —
North County Clinical Research Oceanside California 92056 —
Amit Vijapura, MD and Associates Jacksonville Florida 32256 —
Fidelity Clinical Research Lauderhill Florida 33319 —
Scientific Clinical Research, Inc North Miami Florida 33161 —
Northwest Behavioral Research Center Roswell Georgia 30076 —
Behavioral Biology Research Unit, Johns Hopkins Bayview Campus Baltimore Maryland 21224 —
Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc. Fall River Massachusetts 02720-6009 —
Wayne State University Department of Psychiatry and Behavioral Neurosciences Detroit Michigan 48207 —
Psych Care Consultants Research St Louis Missouri 63128 —
New York VA Medical Center, NYU School of Medicine New York New York 10010 —
Addiction Institute of New York New York New York 10019 —
Duke University Medical Center Addictions Program Durham North Carolina 27705 —
Pahl Pharmaceutical Research, LLC Oklahoma City Oklahoma 73118 —
University of Pennsylvania Treatment Research Center Philadelphia Pennsylvania 19104 —
Providence Behavioral Health Services Everett Washington 98206 —
Puget Sound Health Care Systems Seattle Washington 98108 —

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 NCT00447564, 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 Dec 31, 2018 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00447564 live on ClinicalTrials.gov.

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