A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants

Inclusion Criteria

• Subject must provide written informed consent prior to the conduct of any study-related procedures.
• Male or female, 18-65 years of age, inclusive.
• Primary diagnosis of opioid dependence (DSM-IV-TR).
• Subject is considered clinically stable by their treating healthcare provider and confirmed by the following:
• Subject must be on SL BPN treatment for at least 6 months.
• Subject must have been on a SL BPN dose of 8 mg or less daily for at least the last 90 days prior to Screening.
• No positive urine toxicology results for illicit opioids in the last 90 days.
• Free from significant withdrawal symptoms (score of ≤ 5 on the Clinical Opiate Withdrawal Scale [COWS]), as measured at the Screening Visit.
• Female subjects of childbearing potential must be willing to use a reliable method of contraception during the entire study (Screening Visit to Follow-Up Visit).

Exclusion Criteria

• Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).
• Current diagnosis of chronic pain syndrome requiring chronic opioid treatment, or conditions associated with acute episodic flares that require opioid treatment.
• Pregnant or lactating or planning to become pregnant during the study.
• Hypersensitivity or allergy to ethylene vinyl acetate (EVA)-containing substances or naloxone.
• Recent scarring or tattoos on their upper arms, or a history of keloid scarring.
• Requires current use of agents metabolized through 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.
• Current DSM-IV-TR diagnosis for substance dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, cocaine).
• Significant symptoms or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent.
• Current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study.
• Any pending legal action that could prohibit participation or compliance in the study.
• Exposure to any investigational drug within the 8 weeks prior to Screening.
• Aspartate aminotransferase levels ≥3 X the upper limit of normal, alanine aminotransferase levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the Screening laboratory assessments.
• Clinically significant low platelet count on the Screening laboratory assessments, according to the Investigator.