Efficacy and tolerability of slow-release oral morphine (Substitol®) in opioid substitution treatment – a non-interventional observational study

• Conditions: Mental symptoms; F11.2

• Registration Number: DRKS00010712
• Lead Sponsor: Zentrum für Interdisziplinäre Suchtforschung der Universität Hamburg (ZIS)Universitätsklinikum Hamburg-EppendorfKlinik für Psychiatrie und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-29
• Study Completion: 2019-10-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Opioid dependent patients (F11.2 acc. to ICD-10)
- In OST with d, l-methadone or l-methadone or buprenorphine (including buprenorphine/naloxone) or diamorphine
- Unsatisfactory substitution treatment with d, l-methadone or l-methadone or buprenorphine or diamorphine in mental or physical dimensions (e.g. ongoing craving for heroin, intolerable side effects)
- Willingness to switch from former substitution agent to SROM
- Capable of following the treatment and answering the questionnaires
- Informed consent.

Exclusion Criteria

- According to SmPC (hypersensitivity to the active or one of the other constituents, Ileus, acute abdomen)
- Patients currently treated with SROM (Substitol®).

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mental symptoms (GSI of Brief Symptom Inventory-18), comparison between baseline and month 12

Secondary Outcome Measures

Name	Time	Method
Retention rate at 3, 6 and 12 months, Concomitant drug use, Physical health, Quality of Life, Craving for Heroin, Satisfaction with treatment<br>