A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction

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-TR criteria for current opioid dependence * Females of childbearing potential or a fertile male, must use a reliable means of contraception Exclusion Criteria: * Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS) * Received any medication-assisted treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days * Current diagnosis of chronic pain requiring opioids for treatment * Candidates for short-term opioid treatment (\<6 months) only, or opioid detoxification therapy * Pregnant or lactating female? * Previous hypersensitivity or allergy to BPN, 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), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir) * History of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin * Meet the DSM-IV-TR criteria for dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives) * Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the stu…