Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Titan Pharmaceuticals
With
National Institute on Drug Abuse (NIDA)
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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 study, or obtaining informed consent
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
Exposure to any investigational drug within the previous 8 weeks
Previous exposure to Probuphine, or prior implantation with a placebo implant in the context of a Probuphine clinical trial
Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X the upper limit of normal, alanine aminotransferase (ALT) levels greater than or equal to 3 X the upper limit of normal, total bilirubin greater than or equal to 1.5 X the upper limit of normal, or creatinine greater than 1.5 X upper limit of normal on the screening laboratory assessments
Clinically significant low platelet count on the screening laboratory assessments
