Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
NCT ID: NCT00447564
Last Updated: 2018-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
163 participants
INTERVENTIONAL
2006-10-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A
Probuphine
4 implants
Group B
placebo
4 implants
Interventions
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Probuphine
4 implants
placebo
4 implants
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Titan Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Amit Vijapura, MD and Associates
Jacksonville, Florida, United States
Fidelity Clinical Research
Lauderhill, Florida, United States
Scientific Clinical Research, Inc
North Miami, Florida, United States
Northwest Behavioral Research Center
Roswell, Georgia, 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 University Department of Psychiatry and Behavioral Neurosciences
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
Addiction Institute of New York
New York, New York, United States
Duke University Medical Center 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 Care Systems
Seattle, Washington, United States
Countries
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References
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Ling W, Casadonte P, Bigelow G, Kampman KM, Patkar A, Bailey GL, Rosenthal RN, Beebe KL. Buprenorphine implants for treatment of opioid dependence: a randomized controlled trial. JAMA. 2010 Oct 13;304(14):1576-83. doi: 10.1001/jama.2010.1427.
Other Identifiers
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PRO-805
Identifier Type: -
Identifier Source: org_study_id