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); placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
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 patients with opioid dependence.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Efficacy of Group A verus Group B in the treatment of patients with opioid dependence
Secondary outcome: Efficacy of Group A versus Group B in the treatment of patients with opioid dependenceEfficacy and safety of Probuphine in patient with opioid dependence
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Voluntarily provide written informed consent prior to the conduct of any study related
procedures
- Male or female, 18-65 years of age
- Meet DSM-IV criteria for current opioid dependence
- Females of childbearing potential and fertile males must use a reliable means of
contraception
Exclusion Criteria:
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
- 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
- Received treatment for opioid dependence (e. g., methadone, BPN), within the previous
90 days
- Current diagnosis of chronic pain requiring opioids for treatment
- Candidates for only short term opioid treatment or opioid detoxification therapy
- Pregnant or lactating females
- Previous hypersensitivity or allergy to BPN- or EVA-containing substances or naloxone
- Current use of agents metabolized through 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
- Meet DSM-IV criteria for current dependence on any other psychoactive substances other
than opioids or nicotine (e. g., alcohol, sedatives)
- Current use of benzodiazepines other than physician prescribed use
- Significant medical or psychiatric symptoms or dementia which in the opinion of the
Investigators 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
- Participated in a clinical study within the previous 8 weeks
Locations and Contacts
David Geffen School of Medicine at UCLA, Los Angeles, California 90025, United States
North County Clinical Research, Oceanside, California 92056, United States
Synergy Clinical Research Center, National City, California 91950, United States
Fidelity Clinical Research, Lauderhill, Florida 33319, United States
Amit Vijapura, MD and Associates, Jacksonville, Florida 32256, United States
Scientific Clinical Research, Inc, North Miami, Florida 33161, United States
Northwest Behavioral Research Center, Roswell, Georgia 30076, United States
Behavioral Biology Research Unit, Johns Hopkins Bayview Campus, Baltimore, Maryland 21224, United States
Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc., Fall River, Massachusetts 02720-6009, United States
Wayne State University Department of Psychiatry and Behavioral Neurosciences, Detroit, Michigan 48207, 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 10010, United States
Addiction Institute of New York, New York, New York 10019, United States
Duke University Medical Center 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 Care Systems, Seattle, Washington 98108, United States
Providence Behavioral Health Services, Everett, Washington 98206, United States
Additional Information
Starting date: October 2006
Ending date: August 2008
Last updated: December 20, 2007
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