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
85 participants
INTERVENTIONAL
2010-11-30
2011-11-30
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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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Probuphine
patients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants
Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
Interventions
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Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Titan Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Katherine L. Beebe, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Titan Pharmaceuticals
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
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
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.
White J, Bell J, Saunders JB, Williamson P, Makowska M, Farquharson A, Beebe KL. Open-label dose-finding trial of buprenorphine implants (Probuphine) for treatment of heroin dependence. Drug Alcohol Depend. 2009 Jul 1;103(1-2):37-43. doi: 10.1016/j.drugalcdep.2009.03.008. Epub 2009 Apr 28.
Related Links
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Related Info
Other Identifiers
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PRO-811
Identifier Type: -
Identifier Source: org_study_id