Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

December 27, 2018 updated by: Titan Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
163

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • David Geffen School of Medicine at UCLA
      • National City, California, United States, 91950
        • Synergy Clinical Research Center
      • Oceanside, California, United States, 92056
        • North County Clinical Research
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Amit Vijapura, MD and Associates
      • Lauderhill, Florida, United States, 33319
        • Fidelity Clinical Research
      • North Miami, Florida, United States, 33161
        • Scientific Clinical Research, Inc
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Northwest Behavioral Research Center
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720-6009
        • Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
    • Michigan
      • Detroit, Michigan, United States, 48207
        • Wayne State University Department of Psychiatry and Behavioral Neurosciences
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Psych Care Consultants Research
    • New York
      • New York, New York, United States, 10010
        • New York VA Medical Center, NYU School of Medicine
      • New York, New York, United States, 10019
        • Addiction Institute of New York
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center Addictions Program
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Pahl Pharmaceutical Research, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Treatment Research Center
    • Washington
      • Everett, Washington, United States, 98206
        • Providence Behavioral Health Services
      • Seattle, Washington, United States, 98108
        • Puget Sound Health Care Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Group B
Drug: placebo
4 implants
Active Comparator: Group A
Drug: Probuphine
4 implants

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids
Time Frame: weeks 1-16
weeks 1-16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids
Time Frame: weeks 17-24
weeks 17-24
Mean percent urines negative for illicit opioids
Time Frame: weeks 1-16
weeks 1-16
Mean percent urines negative for illicit opioids
Time Frame: weeks 17-24
weeks 17-24
Proportion (percent) of study completers
Time Frame: weeks 1-16
weeks 1-16
Proportion (percent) of study completers
Time Frame: weeks 17-24
weeks 17-24
Total number of weeks of abstinence
Time Frame: weeks 1-16
weeks 1-16
Total number of weeks of abstinence
Time Frame: weeks 17-24
weeks 17-24
Mean maximal period in weeks of continuous abstinence
Time Frame: weeks 1-16
weeks 1-16
Mean maximal period in weeks of continuous abstinence
Time Frame: weeks 17-24
weeks 17-24
Mean total score on the SOWS
Time Frame: weeks 1-16
weeks 1-16
Mean total score on the SOWS
Time Frame: weeks 17-24
weeks 17-24
Mean total score on the COWS
Time Frame: weeks 1-16
weeks 1-16
Mean total score on the COWS
Time Frame: weeks 17-24
weeks 17-24
Mean subjective opioid cravings assessment (VAS)
Time Frame: weeks 1-16
weeks 1-16
Mean subjective opioid cravings assessment (VAS)
Time Frame: weeks 17-24
weeks 17-24
Patient-rated Clinical Global Impression
Time Frame: weeks 1-16
weeks 1-16
Patient-rated Clinical Global Impression
Time Frame: weeks 17-24
weeks 17-24
Physician-rated Clinical Global Impression
Time Frame: weeks 1-16
weeks 1-16
Physician-rated Clinical Global Impression
Time Frame: weeks 17-24
weeks 17-24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Titan Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-805

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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