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Re-Treatment Study of Probuphine in Opioid Addiction

Primary Purpose

Opioid Dependency

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 Dependency focused on measuring opioid dependence, opioid addiction, buprenorphine, implant, methadone, heroin, suboxone, opioid pain medication, opioid withdrawal

Eligibility Criteria

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

Inclusion Criteria:

  • Subject has voluntarily provided written informed consent prior to conducting any study-related procedures
  • Completion of 24 weeks of treatment in PRO-806
  • Subject has been deemed appropriate for entry into this extension study by the investigator
  • Females of childbearing potential must be willing to use a reliable means of contraception during the entire study.

Exclusion Criteria:

  • An aspartate aminotransferase (AST) levels ≥ 3 X the upper limit of normal, alanine aminotransferase (ALT) levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the screening laboratory assessments
  • A current diagnosis of chronic pain requiring opioids for treatment
  • A pregnant or lactating female
  • Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
  • A history of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin
  • A significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent
  • Any current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study

Sites / Locations

  • David Geffen School of Medicine at UCLA
  • Synergy Clinical Research Center
  • North County Clinical Research
  • Friends Research Institute
  • Amit Vijapura, MD
  • Operation PAR, Inc. - TC Campus
  • Fidelity Clinical Research
  • Scientific Clinical Research, Inc.
  • BPRU, Behavioral Biology Research Center
  • Stanley Street Treatment and Resources, Inc
  • Precise Research Centers
  • Psych Care Consultants Research
  • St. Luke's Roosevelt Hospital Center
  • Duke University Medical Center
  • University of Pennsylvania
  • Carolina Clinical Trials, Inc.
  • University of Vermont
  • Providence Behavioral Health Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probuphine

Arm Description

patients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants

Outcomes

Primary Outcome Measures

Number of subjects with Adverse Events (AEs) as a measure of safety
AEs that occurred after the signing of the informed consent until 4 weeks after the implants have been removed were followed. Serious AEs and AEs that were designated as possibly related to study drug were followed until resolution or stabilization.

Secondary Outcome Measures

Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy
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 total score on Beck Depression Inventory (BDI-II) as a measure of efficacy
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
Overall satisfaction with treatment reported on Patient Satisfaction Survey

Full Information

First Posted
December 15, 2010
Last Updated
December 27, 2018
Sponsor
Titan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01262261
Brief Title
Re-Treatment Study of Probuphine in Opioid Addiction
Official Title
A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (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
Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.

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, implant, methadone, heroin, suboxone, opioid pain medication, opioid withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probuphine
Arm Type
Experimental
Arm Description
patients are first inducted on sublingual buprenorphine 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.
Primary Outcome Measure Information:
Title
Number of subjects with Adverse Events (AEs) as a measure of safety
Description
AEs that occurred after the signing of the informed consent until 4 weeks after the implants have been removed were followed. Serious AEs and AEs that were designated as possibly related to study drug were followed until resolution or stabilization.
Time Frame
29 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy
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 total score on Beck Depression Inventory (BDI-II) as a measure of efficacy
Time Frame
24 weeks
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
Title
Overall satisfaction with treatment reported on Patient Satisfaction Survey
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: Subject has voluntarily provided written informed consent prior to conducting any study-related procedures Completion of 24 weeks of treatment in PRO-806 Subject has been deemed appropriate for entry into this extension study by the investigator Females of childbearing potential must be willing to use a reliable means of contraception during the entire study. Exclusion Criteria: An aspartate aminotransferase (AST) levels ≥ 3 X the upper limit of normal, alanine aminotransferase (ALT) levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the screening laboratory assessments A current diagnosis of chronic pain requiring opioids for treatment A pregnant or lactating female Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir) A history of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin A significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent Any current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L. Beebe, Ph.D.
Organizational Affiliation
Titan Pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Synergy Clinical Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
North County Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Friends Research Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Amit Vijapura, MD
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Operation PAR, Inc. - TC Campus
City
Largo
State/Province
Florida
ZIP/Postal Code
33771
Country
United States
Facility Name
Fidelity Clinical Research
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Scientific Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
BPRU, Behavioral Biology Research Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Stanley Street Treatment and Resources, Inc
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Psych Care Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Carolina Clinical Trials, Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Providence Behavioral Health Services
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20940383
Citation
Ling W, Casadonte P, Bigelow G, Kampman KM, Patkar A, Bailey GL, Rosenthal RN, Beebe KL. Buprenorphine implants for treatment of opioid dependence: a randomized controlled trial. JAMA. 2010 Oct 13;304(14):1576-83. doi: 10.1001/jama.2010.1427.
Results Reference
background
PubMed Identifier
19403243
Citation
White J, Bell J, Saunders JB, Williamson P, Makowska M, Farquharson A, Beebe KL. Open-label dose-finding trial of buprenorphine implants (Probuphine) for treatment of heroin dependence. Drug Alcohol Depend. 2009 Jul 1;103(1-2):37-43. doi: 10.1016/j.drugalcdep.2009.03.008. Epub 2009 Apr 28.
Results Reference
background
Links:
URL
http://www.titanpharm.com
Description
Related Info

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Re-Treatment Study of Probuphine in Opioid Addiction

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