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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 7, 2008
Last Updated Date	January 25, 2013
Start Date ^ICMJE	September 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 23, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: October 7, 2008)	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 ]
Change History	Complete list of historical versions of study NCT00768482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 23, 2012)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: October 7, 2008)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence
Official Title ^ICMJE	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
Brief Summary	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).
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Opioid Dependence
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Probuphine Patients are first inducted on SL BPN, and then switched to 4 Probuphine implants Interventions: Drug: Probuphine (buprenorphine implant) Drug: Sublingual Buprenorphine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	9
Completion Date	December 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00768482
Other Study ID Numbers ^ICMJE	PRO-810
Has Data Monitoring Committee	Yes
Responsible Party	Titan Pharmaceuticals
Study Sponsor ^ICMJE	Titan Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Titan Pharmaceuticals
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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