NCT01262261

Re-Treatment Study of Probuphine in Opioid Addiction

A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Titan Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.

Conditions

• Opioid Dependency

Interventions

Type	Name	Description
DRUG	Probuphine (buprenorphine implant)	Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-12-17
• Last updated: 2018-12-31

Locations

18 sites across 1 country: United States