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A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence (PRO-810)

This study has been terminated.
(This study was terminated for reasons not related to efficacy or safety)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00768482
First Posted: October 8, 2008
Last Update Posted: June 14, 2017
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.
Information provided by (Responsible Party):
Braeburn Pharmaceuticals
  Purpose
This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).

Condition Intervention Phase
Opioid Dependence Drug: Probuphine (buprenorphine implant) Drug: Sublingual Buprenorphine Phase 3

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Cross-Over, Open-Label Study of the Relative Bioavailability of Probuphine Versus Buprenorphine Sublingual Tablets at Steady State in Patients With Opioid Dependence

Resource links provided by NLM:


Further study details as provided by Braeburn Pharmaceuticals:

Primary Outcome Measures:
  • Plasma BPN AUC(0-24)during 24 hours at steady state. [ Time Frame: Day -1, Day -2 and Week 4 ]

Secondary Outcome Measures:
  • Plasma BPN and NorBPN Cmax [ Time Frame: week 4 ]
  • Time to maximum plasma BPN and NorBPN concentration (tmax) [ Time Frame: Day -2, Day -1 and Day 1 ]
  • Plasma BPN and NorBPN AUC(0-24) during 24 hours at steady state [ Time Frame: week 4 ]
  • Change in plasma BPN concentration [ Time Frame: 24 weeks ]
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: approx. 11 weeks (due to study termination) ]
    Adverse events that occurred after the signing of informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and Serious AEs until resolution or stabilization, were followed.


Enrollment: 9
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probuphine
Patients are first inducted on SL BPN, and then switched to 4 Probuphine implants
Drug: Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants)
Drug: Sublingual Buprenorphine
16 mg/day, QD

Detailed Description:
This is an open-label study intended to evaluate the relative bioavailability of 4 Probuphine implants versus 16mg QD sublingual buprenorphine, as determined by plasma BPN AUC(0-24), during 24 hours at steady state. This study will also provide open-label safety and tolerability data in patients treated with Probuphine.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntarily provide written informed consent prior to the conduct of any study related procedures
  • Male or female, 18-75 years of age
  • Meet the 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)
  • 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 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/or anti-coagulant therapy (such as warfarin)
  • Meet the 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, cognitive impairment, or other factors 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
  • Previous participation in a Probuphine clinical trial
  • Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels greater than or equal to 3 X upper limit of normal and/or total bilirubin greater than or equal to 1.5 X upper limit of normal and/or creatinine greater than or equal to 1.5 X upper limit of normal
  • Clinically significant low platelet count with current history of coagulopathy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00768482


Locations
United States, Florida
Segal Institute For Clinical Research
Fort Lauderdale, Florida, United States, 33308
Sponsors and Collaborators
Braeburn Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Braeburn Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00768482     History of Changes
Other Study ID Numbers: PRO-810
First Submitted: October 7, 2008
First Posted: October 8, 2008
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Braeburn Pharmaceuticals:
opioid dependence
opioid addiction
buprenorphine
methadone
heroin
implant
opioid withdrawal
opioid pain medication
suboxone

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