Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence: USA, Various

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Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

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.

http://www.clinicaltrials.gov/ct/show/NCT00447564

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

Study start: October 2006; Expected completion: May 2008

Contact
Please refer to this study by ClinicalTrials.gov identifier NCT00447564

United States, California
David Geffen School of Medicine at UCLA, Los Angeles, California, 90025, United States; Recruiting
Catherine Domier 310-267-5324
Walter Ling, MD, Principal Investigator

North County Clinical Research, Oceanside, California, 92056, United States; Recruiting
Angela Hunt 760-639-4378
Valentin Isacescu, MD, Principal Investigator

Synergy Clinical Research Center, National City, California, 91950, United States; Recruiting
Christine Delgado 619-327-0155
Saleem Ishaque, MD, Principal Investigator

United States, Florida
Fidelity Clinical Research, Lauderhill, Florida, 33319, United States; Recruiting
Stephanie Antonoglou 877-734-2588
David Flaherty, DO, Principal Investigator

Amit Vijapura, MD and Associates, Jacksonville, Florida, 32256, United States; Recruiting
Shirley Roessner 904-733-7333
Amit Vijapura, MD, Principal Investigator

Scientific Clinical Research, Inc, North Miami, Florida, 33161, United States; Recruiting
Stephanie Antonoglou 877-734-2588
Scott Segal, MD, Principal Investigator

United States, Georgia
Northwest Behavioral Research Center, Roswell, Georgia, 30076, United States; Recruiting
Shelby Lewis Radek 678-992-0109
Michael Banov, MD, Principal Investigator

United States, Maryland
Behavioral Biology Research Unit, Johns Hopkins Bayview Campus, Baltimore, Maryland, 21224, United States; Recruiting
Joe Harrison 410-550-3073
George Bigelow, PhD, Principal Investigator

United States, Massachusetts
Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc., Fall River, Massachusetts, 02720-6009, United States; Recruiting
Michelle Rapoza 508-679-5222
Genie Bailey, MD, Principal Investigator

United States, Michigan
Wayne State University Department of Psychiatry and Behavioral Neurosciences, Detroit, Michigan, 48207, United States; Recruiting
Caren Steinmiller 313-577-8257
Mark Greenwald, PhD, Principal Investigator

United States, Missouri
Psych Care Consultants Research, St. Louis, Missouri, 63128, United States; Recruiting
Lali Khan, MD 314-849-1853
Azfar Malik, MD, Principal Investigator

United States, New York
New York VA Medical Center, NYU School of Medicine, New York, New York, 10010, United States; Recruiting
Svetlana Brodsky 212-686-7500 Ext. 3012
Paul Casadonte, MD, Principal Investigator

Addiction Institute of New York, New York, New York, 10019, United States; Recruiting
Neena Ajwani 212-523-2595
Richard Rosenthal, MD, Principal Investigator

United States, North Carolina
Duke University Medical Center Addictions Program, Durham, North Carolina, 27705, United States; Recruiting
Karen McCain 919-668-2198
Ashwin Patkar, MD, Principal Investigator

United States, Oklahoma
Pahl Pharmaceutical Research, LLC, Oklahoma City, Oklahoma, 73118, United States; Recruiting
Jennifer Gingerich 405-525-6500
Jorg Pahl, MD, Principal Investigator

United States, Pennsylvania
University of Pennsylvania Treatment Research Center, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Tiffany Sharkoski 215-222-3200 Ext. 163
Kyle Kampman, MD 215-222-3200
Kyle Kampman, MD, Principal Investigator

United States, Washington
Puget Sound Health Care Systems, Seattle, Washington, 98108, United States; Recruiting
Kevin Wruck 206-277-4872
Andrew Saxon, MD, Principal Investigator

Providence Behavioral Health Services, Everett, Washington, 98206, United States; Recruiting
Keely A'Hearn 425-258-7688
William Dickinson, DO, Principal Investigator

(Please do not PM me in regards to this, I am not affiliated with this research)

 

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Buprenorphine for opioid dependence
DOI:10.1586/ern.09.26
Walter Linga
pages 609-616​

Abstract
As a treatment agent for opioid dependence, buprenorphine is a nearly ideal medication at our current stage of medication development. Unlike methadone, buprenorphine dosage can be rapidly adjusted with minimal potential for inducing severe consequences. In addition to its intrinsic safety, buprenorphine’s relatively low abuse liability in the combination product (i.e., with naloxone as Suboxone®) makes it even more acceptable in regulatory quarters as well as to prescribing physicians. The approval of buprenorphine as a pharmacotherapy for opioid dependence returns to physicians the ability to treat their opioid-dependent patients with an effective opioid-based treatment for the first time in nearly 100 years. Buprenorphine is an opioid, however, and potential for misuse remains, even in combination with naloxone. Whether buprenorphine will be increasingly accepted as a treatment for opioid-dependent patients depends on clinicians recognizing the advantages of its uniquely useful properties while still heeding the need to manage their patients’ therapy with reasonable vigilance.