NCT00630201: PRO-807

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

Completed Phase 3 Last updated 27 December 2018

What this trial tests

Phase 3 trial testing Probuphine (buprenorphine implant) in Opioid Dependence in 62 participants. Completed in 1 February 2009.

Timeline

1 October 2007

Primary endpoint
1 February 2009

1 February 2009

Quick facts

Lead sponsor	Titan Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	1 October 2007
Primary completion	1 February 2009
Estimated completion	1 February 2009
Sites	15 locations across United States

Drugs / interventions tested

• Probuphine (buprenorphine implant) — full drug profile →

Conditions studied

• Opioid Dependence — all drugs for Opioid Dependence →

Sponsor

Titan Pharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Opioid Dependence. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of subjects with adverse events as a measure of safety
  Time frame: approx. 26 weeks
  Adverse events that occurred after the signing of the informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and all Serious AEs until resolution or stabilization, were followed.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Novel medications to treat addictive disorders.
   Montoya ID, Vocci F. · · 2008 · cited 16× · PMID 18803912 · DOI 10.1007/s11920-008-0063-9