Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Titan Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Opioid Dependence

Treatments

Drug: placebo

Drug: Probuphine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00447564

PRO-805

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 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 patients with opioid dependence.

Enrollment

163 patients

Sex

All

Ages

18 to 65 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, 18-65 years of age
Meet 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)
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
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 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
Meet 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 or dementia 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