Status:
TERMINATED
Study of Probuphine in Patients With Opioid Dependence
Lead Sponsor:
Titan Pharmaceuticals
Conditions:
Opioid Dependency
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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. Prob...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00772785
Start Date
September 1 2008
End Date
February 1 2009
Last Update
December 31 2018
Active Locations (1)
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1
Scientific Clinical Research, Inc.
North Miami, Florida, United States, 33161