Re-Treatment Study of Probuphine in Opioid Addiction

Completed · Phase 3

Conditions studied: Opioid Dependency

In brief

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.

Key facts

Study ID

NCT01262261

Run by

Titan Pharmaceuticals

People needed

85

Starts

2010-11-01

Expected to finish

2011-11-01

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…

• Subject has voluntarily provided written informed consent prior to conducting any study-related procedures
• Completion of 24 weeks of treatment in PRO-806
• Subject has been deemed appropriate for entry into this extension study by the investigator
• Females of childbearing potential must be willing to use a reliable means of contraception during the entire study.

You may not qualify if…

• An aspartate aminotransferase (AST) levels ≥ 3 X the upper limit of normal, alanine aminotransferase (ALT) levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the screening laboratory assessments
• A current diagnosis of chronic pain requiring opioids for treatment
• A pregnant or lactating female
• Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
• A history of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin
• A significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent
• Any current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the 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
• North County Clinical Research — Oceanside, California, United States
• Friends Research Institute — Torrance, California, United States
• Amit Vijapura, MD — Jacksonville, Florida, United States
• Operation PAR, Inc. - TC Campus — Largo, Florida, United States
• Fidelity Clinical Research — Lauderhill, Florida, United States
• Scientific Clinical Research, Inc. — North Miami, Florida, United States
• BPRU, Behavioral Biology Research Center — Baltimore, Maryland, United States
• Stanley Street Treatment and Resources, Inc — Fall River, Massachusetts, United States
• Precise Research Centers — Flowood, Mississippi, United States
• Psych Care Consultants Research — St Louis, Missouri, United States
• St. Luke's Roosevelt Hospital Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Carolina Clinical Trials, Inc. — Charleston, South Carolina, United States
• University of Vermont — Burlington, Vermont, United States
• Providence Behavioral Health Services — Everett, Washington, United States

Full record on ClinicalTrials.gov

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