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

Completed · Phase 3

Conditions studied: Opioid Dependence

In brief

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.

Key facts

Study ID

NCT00630201

Run by

Titan Pharmaceuticals

People needed

62

Starts

2007-10-01

Expected to finish

2009-02-01

Last updated by the study team

2018-12-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily provide written informed consent prior to conduct of any study-related procedures
• Completed 24 weeks of treatment in PRO-805
• Deemed appropriate for entry into this extension study by the Investigator
• Females of childbearing potential and fertile males must use a reliable means of contraception

You may not qualify if…

• 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
• 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 anti-coagulant therapy (such as warfarin) or an INR > 1.2
• 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 study

Where it is running

• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Synergy Clinical Research Center — National City, California, United States
• Amit Vijapura, MD — Jacksonville, Florida, United States
• Fidelity Clinical Research, Inc. — Lauderhill, Florida, United States
• Scientific Clinical Research, Inc. — North Miami, Florida, United States
• Behavioral Biology Research Unit, Johns Hopkins Bayview Campus — Baltimore, Maryland, United States
• Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc. — Fall River, Massachusetts, United States
• Wayne State Univ. School of Medicine, Dept of Psychiatry & Behavioral Neuroscience — Detroit, Michigan, United States
• Psych Care Consultants Research — St Louis, Missouri, United States
• New York VA Medical Center, NYU School of Medicine — New York, New York, United States
• Duke Addictions Program — Durham, North Carolina, United States
• Pahl Pharmaceutical Research, LLC — Oklahoma City, Oklahoma, United States
• University of Pennsylvania, Treatment Research Center — Philadelphia, Pennsylvania, United States
• Providence Behavioral Health Services — Everett, Washington, United States
• Puget Sound Health CareSystem — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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