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

Titan Pharmaceuticals

Status and phase

Terminated

Phase 3

Conditions

Opioid Dependence

Treatments

Drug: Sublingual Buprenorphine

Drug: Probuphine (buprenorphine implant)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00768482

PRO-810

Details and patient eligibility

About

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).

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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