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Study of Probuphine in Patients With Opioid Dependence

Information source: Titan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid Dependency

Intervention: Probuphine (buprenorphine implant) (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Titan Pharmaceuticals


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 Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of adverse events

Secondary outcome: Plasma buprenorphine concentration

Detailed 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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: Patients must meet the following eligibility criteria:

- Expected to complete 24 weeks of treatment in PRO-807 or PRO-808

- Voluntarily provide written informed consent prior to the conduct of any

study-related procedures

- Deemed appropriate for entry into this re-treatment study by the Investigator

- Females of childbearing potential and fertile males must use a reliable means of

contraception Exclusion Criteria: Patients are not eligible for enrollment if any of the following criteria are met:

- Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal

and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1. 5 X upper limit of normal and/or creatinine ≥ 1. 5 X upper limit of normal, measured at the time of the Week 20 Visit for the previous trial (PRO-807 or PRO-808), or any time less than 5 weeks prior to the Implant Visit.

- Current diagnosis of chronic pain requiring opioids for treatment

- Pregnant or lactating females

- Current use of agents metabolized through cytochrome P450 3A4 (CYP 3A4) such as azole

antifungals (e. g., ketoconazole), macrolide antibiotics (e. g., erythromycin), and protease inhibitors (e. g., ritonavir, indinavir, and saquinavir)

- Current history of coagulopathy and anti-coagulant therapy (such as warfarin)

- Current use of benzodiazepines other than physician prescribed use

- Significant medical or psychiatric symptoms, cognitive impairment, or other factors

which in the opinion of the Investigator, would preclude compliance with the protocol, patient safety, adequate cooperation in the study, or obtaining informed consent

- Concurrent medical conditions (such as severe respiratory insufficiency) that may

prevent the patient from safely participating in study; and/or any pending legal action that could prohibit participation and/or compliance in the study

Locations and Contacts

Scientific Clinical Research, Inc., North Miami, Florida 33161, United States
Additional Information

Starting date: September 2008
Last updated: January 25, 2013

Page last updated: August 23, 2015

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