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Study of Probuphine in Patients With Opioid Dependence — PRO-809  

Opioid Dependency Clinical Trial

Official title:
An Open-label, Multi-center Extension Study of Probuphine in Patients With Opioid Dependence

Clinical Trial Summary

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 patients with opioid dependence. Patients who have completed at least 24 weeks of treatment in the Open-Label, Multi-Center Study of Probuphine in Patients with Opioid Dependence (PRO-807 Study), will be re-treated with Probuphine over an additional 24 weeks.

Clinical Trial Description

This is a 6-month, open-label, multi-center extension study. It is estimated that approximately 200 patients will be enrolled at approximately 25 sites in the United States (US). Following completion of either the PRO-807(NCT00630201) or PRO-808 studies, eligible patients will be implanted with Probuphine implants in the opposite arm for the PRO-809 study. Safety, BPN plasma levels, and efficacy measures will be collected during the 24-week treatment period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00772785
Study type Interventional
Source Titan Pharmaceuticals
Contact
Status Terminated
Phase Phase 3
Start date September 2008
Completion date February 2009
View Details
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