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

Indivior Europe Limited0 sites57 target enrollmentSeptember 3, 2021

Overview

No summary available.

Registry

who.int

Start Date

September 3, 2021

End Date

September 30, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

•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