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

October 7, 2008
January 25, 2013
September 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
To assess the relative bioavailability of Probuphine versus SL BPN as determined by plasma BPN AUC(0-24)during 24 hours at steady state. [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00768482 on ClinicalTrials.gov Archive Site
  • 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.
  • To evaluate the pharmacokinetics of buprenorphine released by Probuphine in patients with opioid dependence over 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the inter-patient variability in plasma BPN and NorBPN AUC(0-24) for Probuphine and SL BPN during 24 hours at steady state [ Designated as safety issue: No ]
  • To assess maximum plasma BPN and NorBPN concentrations (Cmax) and time to maximum plasma BPN and NorBPN concentration (tmax) and steady stated plasma BPN and Nor BPN concentration (Css) for Probuphine and SL BPN. [ Designated as safety issue: No ]
  • To assess the safety and tolerability of Probuphine [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence
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

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).

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.

Interventional
Phase 3
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Opioid Dependence
  • 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
Experimental: Probuphine
Patients are first inducted on SL BPN, and then switched to 4 Probuphine implants
Interventions:
  • Drug: Probuphine (buprenorphine implant)
  • Drug: Sublingual Buprenorphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00768482
PRO-810
Yes
Titan Pharmaceuticals
Titan Pharmaceuticals
Not Provided
Not Provided
Titan Pharmaceuticals
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP