Back to resultsStudy of Probuphine in Patients With Opioid Dependence (PRO-809)
Primary Purpose
Opioid Dependency
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Probuphine (buprenorphine implant)
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependency focused on measuring opioid dependence, opioid addiction, buprenorphine, methadone, heroin, implant, opioid withdrawal, opioid pain medication, suboxone
Eligibility Criteria
Inclusion Criteria:
Patients must meet the following eligibility criteria:
- Expected to complete 24 weeks of treatment in PRO-807 or PRO-808
- Voluntarily provide written informed consent prior to the conduct of any study-related procedures
- Deemed appropriate for entry into this re-treatment study by the Investigator
- Females of childbearing potential and fertile males must use a reliable means of contraception
Exclusion Criteria:
Patients are not eligible for enrollment if any of the following criteria are met:
- 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, measured at the time of the Week 20 Visit for the previous trial (PRO-807 or PRO-808), or any time less than 5 weeks prior to the Implant Visit.
- 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 history of coagulopathy and anti-coagulant therapy (such as warfarin)
- 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 the study
Sites / Locations
- Scientific Clinical Research, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Probuphine
Arm Description
buprenorphine implant
Outcomes
Primary Outcome Measures
Number of adverse events
Secondary Outcome Measures
Plasma buprenorphine concentration
Full Information
NCT ID
NCT00772785
First Posted
October 9, 2008
Last Updated
December 27, 2018
Sponsor
Titan Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00772785
Brief Title
Study of Probuphine in Patients With Opioid Dependence
Acronym
PRO-809
Official Title
An Open-label, Multi-center Extension Study of Probuphine in Patients With Opioid Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated for reasons not related to efficacy or safety
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Titan Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 patients with opioid dependence. Patients who have completed at least 24 weeks of treatment in the Open-Label, Multi-Center Study of Probuphine in Patients with Opioid Dependence (PRO-807 Study), will be re-treated with Probuphine over an additional 24 weeks.
Detailed Description
This is a 6-month, open-label, multi-center extension study. It is estimated that approximately 200 patients will be enrolled at approximately 25 sites in the United States (US). Following completion of either the PRO-807(NCT00630201) or PRO-808 studies, eligible patients will be implanted with Probuphine implants in the opposite arm for the PRO-809 study. Safety, BPN plasma levels, and efficacy measures will be collected during the 24-week treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependency
Keywords
opioid dependence, opioid addiction, buprenorphine, methadone, heroin, implant, opioid withdrawal, opioid pain medication, suboxone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probuphine
Arm Type
Experimental
Arm Description
buprenorphine implant
Intervention Type
Drug
Intervention Name(s)
Probuphine (buprenorphine implant)
Intervention Description
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants 6-month duration)
Primary Outcome Measure Information:
Title
Number of adverse events
Time Frame
24 WEEKS
Secondary Outcome Measure Information:
Title
Plasma buprenorphine concentration
Time Frame
24 WEEKS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must meet the following eligibility criteria:
Expected to complete 24 weeks of treatment in PRO-807 or PRO-808
Voluntarily provide written informed consent prior to the conduct of any study-related procedures
Deemed appropriate for entry into this re-treatment study by the Investigator
Females of childbearing potential and fertile males must use a reliable means of contraception
Exclusion Criteria:
Patients are not eligible for enrollment if any of the following criteria are met:
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, measured at the time of the Week 20 Visit for the previous trial (PRO-807 or PRO-808), or any time less than 5 weeks prior to the Implant Visit.
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 history of coagulopathy and anti-coagulant therapy (such as warfarin)
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 the study
Facility Information:
Facility Name
Scientific Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Probuphine in Patients With Opioid Dependence
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