Re-Treatment Study of Probuphine in Opioid Addiction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01262261
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Braeburn Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Opioid Dependency Drug: Probuphine (buprenorphine implant) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction
Study Start Date : November 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Probuphine
patients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants
Drug: Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.

Primary Outcome Measures :
  1. Number of subjects with Adverse Events (AEs) as a measure of safety [ Time Frame: 29 weeks ]
    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 :
  1. Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy [ Time Frame: 24 weeks ]
  2. Percent of subjects retained as a measure of efficacy [ Time Frame: 24 weeks ]
  3. Percent of subjects reporting illicit drug use as a measure of efficacy [ Time Frame: 24 weeks ]
  4. Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy [ Time Frame: 24 weeks ]
  5. Mean total score on SOWS as a measure of efficacy [ Time Frame: 24 weeks ]
  6. Mean total score on COWS as a measure of efficacy [ Time Frame: 24 weeks ]
  7. Mean subjective opioid cravings scores as a measure of efficacy [ Time Frame: 24 weeks ]
  8. Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy [ Time Frame: 24 weeks ]
  9. Patient-rated opioid use and problems Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ]
  10. Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ]
  11. Overall satisfaction with treatment reported on Patient Satisfaction Survey [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01262261

United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90025
Synergy Clinical Research Center
National City, California, United States, 91950
North County Clinical Research
Oceanside, California, United States, 92056
Friends Research Institute
Torrance, California, United States, 90502
United States, Florida
Amit Vijapura, MD
Jacksonville, Florida, United States, 32256
Operation PAR, Inc. - TC Campus
Largo, Florida, United States, 33771
Fidelity Clinical Research
Lauderhill, Florida, United States, 33319
Scientific Clinical Research, Inc.
North Miami, Florida, United States, 33161
United States, Maryland
BPRU, Behavioral Biology Research Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Stanley Street Treatment and Resources, Inc
Fall River, Massachusetts, United States, 02720
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Missouri
Psych Care Consultants Research
Saint Louis, Missouri, United States, 63128
United States, New York
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Carolina Clinical Trials, Inc.
Charleston, South Carolina, United States, 29407
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
United States, Washington
Providence Behavioral Health Services
Everett, Washington, United States, 98201
Sponsors and Collaborators
Braeburn Pharmaceuticals
Principal Investigator: Katherine L. Beebe, Ph.D. Titan Pharmaceuticals

Additional Information:
Responsible Party: Braeburn Pharmaceuticals Identifier: NCT01262261     History of Changes
Other Study ID Numbers: PRO-811
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Braeburn Pharmaceuticals:
opioid dependence
opioid addiction
opioid pain medication
opioid withdrawal

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists