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:
Information provided by (Responsible Party):
Titan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00768482
First received: October 7, 2008
Last updated: January 25, 2013
Last verified: October 2012
  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: Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 Titan Pharmaceuticals:

Primary Outcome Measures:
  • Plasma BPN AUC(0-24)during 24 hours at steady state. [ Time Frame: Day -1, Day -2 and Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma BPN and NorBPN Cmax [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • Time to maximum plasma BPN and NorBPN concentration (tmax) [ Time Frame: Day -2, Day -1 and Day 1 ] [ Designated as safety issue: No ]
  • Plasma BPN and NorBPN AUC(0-24) during 24 hours at steady state [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • Change in plasma BPN concentration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: approx. 11 weeks (due to study termination) ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768482

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

Additional Information:
No publications provided

Responsible Party: Titan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00768482     History of Changes
Other Study ID Numbers: PRO-810
Study First Received: October 7, 2008
Last Updated: January 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Titan 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
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 30, 2014