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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00026176

Enrollment

200

Registered

2021-09-03

Start date

2021-11-19

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F11

Interventions

Group 1: Patients in opioid substitution therapy (OST) with the drug Suboxone® sublingualfilm. The maximum observation period in the study is 12 months. The planned observation time points are baselin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactJens Reimer

Vorstand Zentrum für Interdisziplinäre Suchtforschung der Universität Hamburg, Universitätsklinikum Hamburg-Eppendorf,Klinik und Poliklinik für Psychiatrie und Psychotherapie

reimer@uke.de+49 (0)40 7410 57900

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026