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Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Primary Purpose

Opioid Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Probuphine
placebo
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 the conduct of any study related procedures
  • Male or female, 18-65 years of age
  • Meet 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)
  • 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
  • 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 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
  • Meet 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 or dementia 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids

Secondary Outcome Measures

The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids
Mean percent urines negative for illicit opioids
Mean percent urines negative for illicit opioids
Proportion (percent) of study completers
Proportion (percent) of study completers
Total number of weeks of abstinence
Total number of weeks of abstinence
Mean maximal period in weeks of continuous abstinence
Mean maximal period in weeks of continuous abstinence
Mean total score on the SOWS
Mean total score on the SOWS
Mean total score on the COWS
Mean total score on the COWS
Mean subjective opioid cravings assessment (VAS)
Mean subjective opioid cravings assessment (VAS)
Patient-rated Clinical Global Impression
Patient-rated Clinical Global Impression
Physician-rated Clinical Global Impression
Physician-rated Clinical Global Impression

Full Information

First Posted
March 12, 2007
Last Updated
December 27, 2018
Sponsor
Titan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00447564
Brief Title
Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center 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 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 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
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 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.

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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Title
Group B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Probuphine
Intervention Description
4 implants
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
4 implants
Primary Outcome Measure Information:
Title
The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids
Time Frame
weeks 1-16
Secondary Outcome Measure Information:
Title
The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids
Time Frame
weeks 17-24
Title
Mean percent urines negative for illicit opioids
Time Frame
weeks 1-16
Title
Mean percent urines negative for illicit opioids
Time Frame
weeks 17-24
Title
Proportion (percent) of study completers
Time Frame
weeks 1-16
Title
Proportion (percent) of study completers
Time Frame
weeks 17-24
Title
Total number of weeks of abstinence
Time Frame
weeks 1-16
Title
Total number of weeks of abstinence
Time Frame
weeks 17-24
Title
Mean maximal period in weeks of continuous abstinence
Time Frame
weeks 1-16
Title
Mean maximal period in weeks of continuous abstinence
Time Frame
weeks 17-24
Title
Mean total score on the SOWS
Time Frame
weeks 1-16
Title
Mean total score on the SOWS
Time Frame
weeks 17-24
Title
Mean total score on the COWS
Time Frame
weeks 1-16
Title
Mean total score on the COWS
Time Frame
weeks 17-24
Title
Mean subjective opioid cravings assessment (VAS)
Time Frame
weeks 1-16
Title
Mean subjective opioid cravings assessment (VAS)
Time Frame
weeks 17-24
Title
Patient-rated Clinical Global Impression
Time Frame
weeks 1-16
Title
Patient-rated Clinical Global Impression
Time Frame
weeks 17-24
Title
Physician-rated Clinical Global Impression
Time Frame
weeks 1-16
Title
Physician-rated Clinical Global Impression
Time Frame
weeks 17-24

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 the conduct of any study related procedures Male or female, 18-65 years of age Meet 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) 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 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 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 Meet 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 or dementia 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
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
Amit Vijapura, MD and Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
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
Northwest Behavioral Research Center
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720-6009
Country
United States
Facility Name
Wayne State University Department of Psychiatry and Behavioral Neurosciences
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48207
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
ZIP/Postal Code
10010
Country
United States
Facility Name
Addiction Institute of New York
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Duke University Medical Center 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
98206
Country
United States
Facility Name
Puget Sound Health Care Systems
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
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
derived

Learn more about this trial

Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

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