A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence (PRO-810)
Primary Purpose
Opioid Dependence
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Probuphine (buprenorphine implant)
Sublingual Buprenorphine
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring opioid dependence, opioid addiction, buprenorphine, methadone, heroin, implant, opioid withdrawal, opioid pain medication, suboxone
Eligibility Criteria
Inclusion Criteria:
- Voluntarily provide written informed consent prior to the conduct of any study related procedures
- Male or female, 18-75 years of age
- Meet the DSM-IV criteria for current opioid dependence
- Females of childbearing potential and fertile males must use a reliable means of contraception
Exclusion Criteria:
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
- 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 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/or anti-coagulant therapy (such as warfarin)
- Meet the 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, cognitive impairment, or other factors 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
- Previous participation in a Probuphine clinical trial
- Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels greater than or equal to 3 X upper limit of normal and/or total bilirubin greater than or equal to 1.5 X upper limit of normal and/or creatinine greater than or equal to 1.5 X upper limit of normal
- Clinically significant low platelet count with current history of coagulopathy
Sites / Locations
- Segal Institute For Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Probuphine
Arm Description
Patients are first inducted on SL BPN, and then switched to 4 Probuphine implants
Outcomes
Primary Outcome Measures
Plasma BPN AUC(0-24)during 24 hours at steady state.
Secondary Outcome Measures
Plasma BPN and NorBPN Cmax
Time to maximum plasma BPN and NorBPN concentration (tmax)
Plasma BPN and NorBPN AUC(0-24) during 24 hours at steady state
Change in plasma BPN concentration
Number of subjects with adverse events as a measure of safety and tolerability
Adverse events that occurred after the signing of informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and Serious AEs until resolution or stabilization, were followed.
Full Information
NCT ID
NCT00768482
First Posted
October 7, 2008
Last Updated
December 27, 2018
Sponsor
Titan Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00768482
Brief Title
A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence
Acronym
PRO-810
Official Title
A Single Cross-Over, Open-Label Study of the Relative Bioavailability of Probuphine Versus Buprenorphine Sublingual Tablets at Steady State 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
December 2008 (Actual)
Study Completion Date
December 2008 (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
This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).
Detailed Description
This is an open-label study intended to evaluate the relative bioavailability of 4 Probuphine implants versus 16mg QD sublingual buprenorphine, as determined by plasma BPN AUC(0-24), during 24 hours at steady state. This study will also provide open-label safety and tolerability data in patients treated with Probuphine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
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
Crossover Assignment
Masking
None (Open Label)
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probuphine
Arm Type
Experimental
Arm Description
Patients are first inducted on SL BPN, and then switched to 4 Probuphine implants
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)
Intervention Type
Drug
Intervention Name(s)
Sublingual Buprenorphine
Intervention Description
16 mg/day, QD
Primary Outcome Measure Information:
Title
Plasma BPN AUC(0-24)during 24 hours at steady state.
Time Frame
Day -1, Day -2 and Week 4
Secondary Outcome Measure Information:
Title
Plasma BPN and NorBPN Cmax
Time Frame
week 4
Title
Time to maximum plasma BPN and NorBPN concentration (tmax)
Time Frame
Day -2, Day -1 and Day 1
Title
Plasma BPN and NorBPN AUC(0-24) during 24 hours at steady state
Time Frame
week 4
Title
Change in plasma BPN concentration
Time Frame
24 weeks
Title
Number of subjects with adverse events as a measure of safety and tolerability
Description
Adverse events that occurred after the signing of informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and Serious AEs until resolution or stabilization, were followed.
Time Frame
approx. 11 weeks (due to study termination)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntarily provide written informed consent prior to the conduct of any study related procedures
Male or female, 18-75 years of age
Meet the DSM-IV criteria for current opioid dependence
Females of childbearing potential and fertile males must use a reliable means of contraception
Exclusion Criteria:
Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
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 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/or anti-coagulant therapy (such as warfarin)
Meet the 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, cognitive impairment, or other factors 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
Previous participation in a Probuphine clinical trial
Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels greater than or equal to 3 X upper limit of normal and/or total bilirubin greater than or equal to 1.5 X upper limit of normal and/or creatinine greater than or equal to 1.5 X upper limit of normal
Clinically significant low platelet count with current history of coagulopathy
Facility Information:
Facility Name
Segal Institute For Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.titanpharm.com
Description
Related Info
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A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence
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