Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Titan Pharmaceuticals
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
