Study of Probuphine in Patients With Opioid Dependence (PRO-809)

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: NCT00772785
Recruitment Status : Terminated (This study was terminated for reasons not related to efficacy or safety)
First Posted : October 15, 2008
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Braeburn Pharmaceuticals

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 patients with opioid dependence. Patients who have completed at least 24 weeks of treatment in the Open-Label, Multi-Center Study of Probuphine in Patients with Opioid Dependence (PRO-807 Study), will be re-treated with Probuphine over an additional 24 weeks.

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

Detailed Description:
This is a 6-month, open-label, multi-center extension study. It is estimated that approximately 200 patients will be enrolled at approximately 25 sites in the United States (US). Following completion of either the PRO-807(NCT00630201) or PRO-808 studies, eligible patients will be implanted with Probuphine implants in the opposite arm for the PRO-809 study. Safety, BPN plasma levels, and efficacy measures will be collected during the 24-week treatment period.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Extension Study of Probuphine in Patients With Opioid Dependence
Study Start Date : September 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Probuphine
buprenorphine implant
Drug: Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants 6-month duration)

Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: 24 WEEKS ]

Secondary Outcome Measures :
  1. Plasma buprenorphine concentration [ 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)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients must meet the following eligibility criteria:

  • Expected to complete 24 weeks of treatment in PRO-807 or PRO-808
  • Voluntarily provide written informed consent prior to the conduct of any study-related procedures
  • Deemed appropriate for entry into this re-treatment study by the Investigator
  • Females of childbearing potential and fertile males must use a reliable means of contraception

Exclusion Criteria:

Patients are not eligible for enrollment if any of the following criteria are met:

  • 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, measured at the time of the Week 20 Visit for the previous trial (PRO-807 or PRO-808), or any time less than 5 weeks prior to the Implant Visit.
  • 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 history of coagulopathy and anti-coagulant therapy (such as warfarin)
  • 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 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): NCT00772785

United States, Florida
Scientific Clinical Research, Inc.
North Miami, Florida, United States, 33161
Sponsors and Collaborators
Braeburn Pharmaceuticals

Responsible Party: Braeburn Pharmaceuticals Identifier: NCT00772785     History of Changes
Other Study ID Numbers: PRO-809
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

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

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists