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
Subject has voluntarily provided written informed consent prior to conducting any study-related procedures
Completion of 24 weeks of treatment in PRO-806
Subject has been deemed appropriate for entry into this extension study by the investigator
Females of childbearing potential must be willing to use a reliable means of contraception during the entire study.
You may not be if
An aspartate aminotransferase (AST) levels ≥ 3 X the upper limit of normal, alanine aminotransferase (ALT) 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
A current diagnosis of chronic pain requiring opioids for treatment
A pregnant or lactating female
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)
A history of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin
A 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 study, or obtaining informed consent
Any current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study
Clareo Health | Re-Treatment Study of Probuphine in Opioid Addiction
