Clinical Trials Directory

Trials / Completed

CompletedNCT00447564

Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
163 (actual)
Sponsor
Titan Pharmaceuticals · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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 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.

Conditions

Interventions

TypeNameDescription
DRUGProbuphine4 implants
DRUGplacebo4 implants

Timeline

Start date
2006-10-01
Primary completion
2008-07-01
Completion
2008-07-01
First posted
2007-03-14
Last updated
2018-12-31

Locations

18 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00447564. Inclusion in this directory is not an endorsement.