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Completed Phase 3 Interventional

Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

ClinicalTrials.gov ID: NCT00630201

Public ClinicalTrials.gov record NCT00630201. 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 20, 2026, 7:05 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

An Open-Label, Multi-Center Extension 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 (buprenorphine implant) 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 patient with opioid dependence. Patients who have completed 24 weeks of treatment in the Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence, will be re-treated with Probuphine over an additional 24 weeks.

Study identification

NCT ID
NCT00630201
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Titan Pharmaceuticals
Industry
Enrollment
62 participants

Conditions and interventions

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 2007 (Type not available)
Primary completion
Feb 2009 (Actual)
Completion
Feb 2009 (Actual)
Last update posted
Dec 31, 2018

2007 – 2009

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
15
Facility City State ZIP Site status
David Geffen School of Medicine at UCLA Los Angeles California — —
Synergy Clinical Research Center National City California 91950 —
Amit Vijapura, MD Jacksonville Florida 32256 —
Fidelity Clinical Research, Inc. Lauderhill Florida — —
Scientific Clinical Research, Inc. North Miami Florida 33161 —
Behavioral Biology Research Unit, Johns Hopkins Bayview Campus Baltimore Maryland — —
Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc. Fall River Massachusetts — —
Wayne State Univ. School of Medicine, Dept of Psychiatry & Behavioral Neuroscience Detroit Michigan — —
Psych Care Consultants Research St Louis Missouri 63128 —
New York VA Medical Center, NYU School of Medicine New York New York — —
Duke 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 98201-1067 —
Puget Sound Health CareSystem Seattle Washington — —

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 NCT00630201, 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 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00630201 live on ClinicalTrials.gov.

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