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Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence (PRO-807)

Primary Purpose

Opioid Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Probuphine (buprenorphine implant)
Sponsored by
Titan Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • David Geffen School of Medicine at UCLA
  • Synergy Clinical Research Center
  • Amit Vijapura, MD
  • Fidelity Clinical Research, Inc.
  • Scientific Clinical Research, Inc.
  • Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
  • Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
  • Wayne State Univ. School of Medicine, Dept of Psychiatry & Behavioral Neuroscience
  • Psych Care Consultants Research
  • New York VA Medical Center, NYU School of Medicine
  • Duke Addictions Program
  • Pahl Pharmaceutical Research, LLC
  • University of Pennsylvania, Treatment Research Center
  • Providence Behavioral Health Services
  • Puget Sound Health CareSystem

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probuphine

Arm Description

buprenorphine implant

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Buprenorphine concentration in plasma
Percent of urine samples that are negative for illicit opioids
Percent of subjects retained as a measure of efficacy
Percent of subjects reporting illicit drug use as a measure of efficacy
Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy
Mean total score on SOWS as a measure of efficacy
Mean total score on COWS as a measure of efficacy
Mean subjective opioid cravings scores as a measure of efficacy
Mean composite score Drug Problems area of Addiction Severity Index
Patient-rated Opioid use and Problems Responder Analysis as a measure of efficacy
Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy

Full Information

First Posted
February 26, 2008
Last Updated
December 27, 2018
Sponsor
Titan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00630201
Brief Title
Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
Acronym
PRO-807
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
Completed
Study Start Date
October 2007 (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 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.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (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 subjects with adverse events as a measure of safety
Description
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.
Time Frame
approx. 26 weeks
Secondary Outcome Measure Information:
Title
Buprenorphine concentration in plasma
Time Frame
24 weeks
Title
Percent of urine samples that are negative for illicit opioids
Time Frame
24 weeks
Title
Percent of subjects retained as a measure of efficacy
Time Frame
24 weeks
Title
Percent of subjects reporting illicit drug use as a measure of efficacy
Time Frame
24 weeks
Title
Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy
Time Frame
24 weeks
Title
Mean total score on SOWS as a measure of efficacy
Time Frame
24 weeks
Title
Mean total score on COWS as a measure of efficacy
Time Frame
24 weeks
Title
Mean subjective opioid cravings scores as a measure of efficacy
Time Frame
24 weeks
Title
Mean composite score Drug Problems area of Addiction Severity Index
Time Frame
Baseline and End of Treatment
Title
Patient-rated Opioid use and Problems Responder Analysis as a measure of efficacy
Time Frame
24 weeks
Title
Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy
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: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Synergy Clinical Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Amit Vijapura, MD
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Fidelity Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
Country
United States
Facility Name
Scientific Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
City
Fall River
State/Province
Massachusetts
Country
United States
Facility Name
Wayne State Univ. School of Medicine, Dept of Psychiatry & Behavioral Neuroscience
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Psych Care Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
New York VA Medical Center, NYU School of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
Duke Addictions Program
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Pahl Pharmaceutical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
University of Pennsylvania, Treatment Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Providence Behavioral Health Services
City
Everett
State/Province
Washington
ZIP/Postal Code
98201-1067
Country
United States
Facility Name
Puget Sound Health CareSystem
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

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