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

• Conditions: F11; Mental and behavioural disorders due to use of opioids

• Registration Number: DRKS00026176
• Lead Sponsor: Indivior Europe Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-03
• Study Completion: 2023-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with Suboxone sublingual film in terms of administration, ease of use, taste, application time and stigma, evaluated per VAS scale.<br>The VAS values of the five individual factors of the primary target criterion are combined into one value by averaging.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction, evaluated with TSQM-9 questionnaire (IQVIA);<br>Therapy compliance to treatment with Suboxone Sublingualfilm (adherence, rate of dose adjustments);<br>Rate of patients with co-use of other psychoactive substances (patient assessment, laboratory assessment);<br>Intensity of withdrawal symptoms and craving, by investigator assessment (COWS), and patient assessment (VAS);<br>Quality of life (OSTQOL-38 questionnaire);<br>Safety of use of Suboxone Sublingualfilm (frequency of serious and non-serious adverse event or drug reactions)