Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
NCT ID: NCT00630201
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
62 participants
INTERVENTIONAL
2007-10-31
2009-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Probuphine
buprenorphine implant
Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Titan Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Synergy Clinical Research Center
National City, California, United States
Amit Vijapura, MD
Jacksonville, Florida, United States
Fidelity Clinical Research, Inc.
Lauderhill, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, 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, United States
New York VA Medical Center, NYU School of Medicine
New York, New York, United States
Duke 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 CareSystem
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO-807
Identifier Type: -
Identifier Source: org_study_id