Opioid maintenance treatment (OMT) is an important factor in the medical care of opioid-dependent patients. Qualified OMT combined with general medical care and psychosocial support is effective in reduction of morbidity and mortality of opioid dependent patients.
Conditions
Interventions
Trade Name: L-Polamidon Solution
Pharmaceutical Form: Oral solution
INN or Proposed INN: Levomethadone hydrochloride
CAS Number: 5967-73-7
Other descriptive name: LEVOMETHADONE HYDROCHLORIDE
Concentra
Sponsors
Medical University Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Medical or compliance-related psychological or social-environmental reasons for OMT optimization as determined by routine clinical screening procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Severe psychiatric condition (e.g. psychosis, suicidality, depression, over aggressive or dissocial behavior) preventing study participation and systematic acquisition of the study-relevant data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This clinical trial aims to systematically collect the treatment related data during the standard clinical OMT course including eventual medication switches. The patients on OMT which manifest with medical, psychological and social-environmental reasons for treatment optimization (incl. the switch of OMT-medication) will be systematically monitored during the treatment regarding their addiction-related behavioral parameters, side-effects, compliance parameters and treatment satisfaction. This study aims to investigate to what extent patient’s satisfaction with the current OMT treatment influences compliance and outcome. ;Secondary Objective: In addition, detailed data, e.g. timing of administration and dose ratio, regarding treatment switch by transferring patients from methadone or buprenorphine to slow-release morphine will be gathered.;Primary end point(s): This clinical trial aims to systematically collect the treatment related data during the standard clinical OMT course. This study aims to investigate to what extent patient’s satisfaction with the current OMT treatment influences compliance and outcome.;Timepoint(s) of evaluation of this end point: end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In addition, detailed data, e.g. timing of administration and dose ratio, regarding treatment switch by transferring patients from methadone or buprenThe secondary study aims consider treatment specific effects regarding: • retention in treatment • substance use and associated risk behavior (ODAS) • subjective somatic and psychic complaints assessed by self-reporting based on validated instru-ments (POMS) • satisfaction with treatment (TSQM) • dose ratio for treatment switch from buprenorphine to SROM • dose ratio for treatment switch from methadone to SROM • dose ratio for treatment switch from L-methadone to SROMorphine to slow-release morphine will be gathered. ;Timepoint(s) of evaluation of this end point: end of study | — |
Countries
Austria
Contacts
Public ContactDepartment of Psychiatry
Medical University Innsbruck
Outcome results
None listed