Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
PRO-807
An Open-Label, Multi-Center Extension Study Of Probuphine in Patients With Opioid Dependence
1 other identifier
interventional
62
1 country
15
Brief 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 (buprenorphine implant) 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 patient with opioid dependence. Patients who have completed 24 weeks of treatment in the Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence, will be re-treated with Probuphine over an additional 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2007
Shorter than P25 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedDecember 31, 2018
June 1, 2017
1.3 years
February 26, 2008
December 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with adverse events as a measure of safety
Adverse events that occurred after the signing of the informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and all Serious AEs until resolution or stabilization, were followed.
approx. 26 weeks
Secondary Outcomes (11)
Buprenorphine concentration in plasma
24 weeks
Percent of urine samples that are negative for illicit opioids
24 weeks
Percent of subjects retained as a measure of efficacy
24 weeks
Percent of subjects reporting illicit drug use as a measure of efficacy
24 weeks
Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy
24 weeks
- +6 more secondary outcomes
Study Arms (1)
Probuphine
EXPERIMENTALbuprenorphine implant
Interventions
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration).
Eligibility Criteria
You may qualify if:
- Voluntarily provide written informed consent prior to conduct of any study-related procedures
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Synergy Clinical Research Center
National City, California, 91950, United States
Amit Vijapura, MD
Jacksonville, Florida, 32256, United States
Fidelity Clinical Research, Inc.
Lauderhill, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, 33161, 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, 63128, United States
New York VA Medical Center, NYU School of Medicine
New York, New York, United States
Duke 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
Providence Behavioral Health Services
Everett, Washington, 98201-1067, United States
Puget Sound Health CareSystem
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2008
First Posted
March 6, 2008
Study Start
October 1, 2007
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
December 31, 2018
Record last verified: 2017-06