Patient-relevant outcomes in the routine treatment of patients with Opioid Use Disorder (OUD) in Germany using Suboxone® Sublingual Film - PROFI

Indivior Europe Limited0 个研究点目标入组 57 人开始时间: 2021年9月3日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Male or female patients;
•Age >= 18 years;
•Diagnosis of opioid dependance (ICD10 F11.2);
•Indication for opioid substitution therapy (OST);
•Not pre-treated or pre-treated with OST;
•Decision for therapy with Suboxone Sublingual Film has been made;
•Written informed consent from patients to participate in the study and to share personal and health data

•Patient inclusion is generally subject to the decision of the attending physician. In this context, the instructions given below must be observed in accordance with the valid summary of product characteristics (SmPC) for Suboxone® Sublingual Film (in-label use):
•Existing or known hypersensitivity to one of the active substances or to an additional ingredient of the medicinal product according to section 6.1 of the SmPC;
•Severe respiratory insufficiency;
•Severe liver dysfunction;
•Acute alcohol abuse or delirium tremens;
•Concurrent use of an opioid antagonist (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence

发起方