Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence (PRO-807)

Titan Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Opioid Dependence

Treatments

Drug: Probuphine (buprenorphine implant)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00630201

PRO-807

Details and patient eligibility

About

Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patient with opioid dependence. Patients who have completed 24 weeks of treatment in the Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence, will be re-treated with Probuphine over an additional 24 weeks.

Enrollment

62 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Voluntarily provide written informed consent prior to conduct of any study-related procedures
Completed 24 weeks of treatment in PRO-805
Deemed appropriate for entry into this extension study by the Investigator
Females of childbearing potential and fertile males must use a reliable means of contraception

Exclusion criteria

Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal and/or creatinine ≥ 1.5 X upper limit of normal
Current diagnosis of chronic pain requiring opioids for treatment
Pregnant or lactating females
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 anti-coagulant therapy (such as warfarin) or an INR > 1.2
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 Investigator, 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