Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
Information source: Titan Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid Dependence
Intervention: Probuphine (Drug)
Phase: Phase 3
Status: Enrolling by invitation
Sponsored by: Titan Pharmaceuticals
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. Probuphine 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.
Clinical Details
Official title: An Open-Label, Multi-Center Extension Study Of Probuphine in Patients With Opioid Dependence
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the safety of Probuphine in patients who have completed 24 weeks of treatment and who will be re-treated with Probuphine
Secondary outcome: To evaluate the efficacy of Probuphine through pharmacokinetic analyses in patients who have completed 24 weeks of treatment and who will be re-treated with Probuphine
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
David Geffen School of Medicine at UCLA, Los Angeles, California, United States
Synergy Clinical Research Center, National City, California 91950, United States
Fidelity Clinical Research, Inc., Lauderhill, Florida, United States
Scientific Clinical Research, Inc., Jacksonville, Florida 32256, United States
Jacksonville, Florida 32256, 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 63128, United States
New York VA Medical Center, NYU School of Medicine, New York, New York, United States
Duke Addictions Program, Durham, North Carolina 27705, United States
Pahl Pharmaceutical Research, LLC, Oklahoma City, Oklahoma 73118, United States
University of Pennsylvania, Treatment Research Center, Philadelphia, Pennsylvania 19104, United States
Puget Sound Health CareSystem, Seattle, Washington, United States
Providence Behavioral Health Services, Everett, Washington 98201-1067, United States
Additional Information
Starting date: October 2007
Ending date: January 2009
Last updated: May 7, 2008
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