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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00010712
Enrollment
200
Registered
2016-08-29
Start date
2016-07-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Mental symptoms F11.2

Interventions

Group 1: Patients in OST with slow release oral morphine will be observed over a 12-months Periode with 5 Points of assessment

Sponsors

Zentrum für Interdisziplinäre Suchtforschung der Universität Hamburg (ZIS)Universitätsklinikum Hamburg-EppendorfKlinik für Psychiatrie und Psychotherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Mental symptoms (GSI of Brief Symptom Inventory-18), comparison between baseline and month 12

Secondary

MeasureTime frame
Retention rate at 3, 6 and 12 months, Concomitant drug use, Physical health, Quality of Life, Craving for Heroin, Satisfaction with treatment

Countries

Germany

Contacts

Public ContactUwe Verthein

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

u.verthein@uke.uni-hamburg.de+49 40 7410 57901

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 23, 2026