NCT00630201

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

An Open-Label, Multi-Center Extension Study Of Probuphine in Patients With Opioid Dependence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (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 (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.

Conditions

• Opioid Dependence

Interventions

Type	Name	Description
DRUG	Probuphine (buprenorphine implant)	Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration).

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-03-06
• Last updated: 2018-12-31

Locations

15 sites across 1 country: United States