A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence - Full Text View

Sponsor:	Titan Pharmaceuticals
Information provided by:	Titan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00768482

Purpose

This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine implants.

Condition	Intervention	Phase
Opioid Dependence	Drug: Probuphine Drug: Sublingual Buprenorphine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Titan Pharmaceuticals:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	16
Study Start Date:	September 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Probuphine: Experimental Patients are first induced on SL BPN, and then switched to 4 Probuphine implants	Drug: Probuphine 4 implants Drug: Sublingual Buprenorphine

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

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Titan Pharmaceuticals, Inc. ( Katherine Beebe, Ph.D, Senior Vice President, Clinical Development and Medical Affairs )
Study ID Numbers:	PRO-810
Study First Received:	October 7, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00768482 History of Changes
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:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Buprenorphine

Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on March 18, 2010