Comparative on mental and physical well-being and impairment in opioid dependent patients undergoing substitution treatment with methadone, buprenorphine and diamorphine.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017644

Enrollment

1000

Registered

2019-09-02

Start date

2019-07-01

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

F11.2 F11.0

Interventions

Group 1: Patients between 18 and 80 years of age who have been treated with the drug methadone or levomethadone for at least 6 months in substitution treatment in a GP's practice or an outpatient addi

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) at least 6 months in substitution treatment with the current substitute 2) at least 18 years old 3) treatment with one of the indicated substitutes (methadone, levomethadone, buprenorphine, diamorphine, morphine)

Exclusion criteria

Exclusion criteria: 1) shorter than 6 months in substitution treatment with the current substitute 2) under 18 years of age

Design outcomes

Primary

Measure	Time frame
A questionnaire battery consisting of the following questionnaires is available as measuring instruments: 1) SEL scales for recording quality of life (Averbeck et al., 1997), short form with 28 items, self-assessment of health-related quality of life. 2) HSCL-25 - Hopkins Symptom Checklist 25 (Petermann & Brähler, 2013), recording of symptoms of depression and anxiety (self-evaluation). 3) BBS Baseler Befindlichkeits-Skala (Hobi, 1985), 16 bipolar items on well-being (self-evaluation). 4) Oslo 3-Items Support Scale (Kilpeläinen et al., 2008). 5) Big Five Inventory (BFI-K) short version (Rammstedt & John, 2005), recording of the Big 5 personality traits. 6) Self-created sociodemographic questionnaire for the collection of personal key data. The aim of the study is to compare the different substitutes with regard to the dependent variables of the questionnaires (SEL, HSCL-25, BBS). It is calculated whether there are significant differences in the mean values of the individual substitute groups in relation to the constructs of the questionnaires. Possible influences due to the perception of social support (Oslo Support Scale), personality (BFI-K) or certain sociodemographic characteristics (age, gender, treatment-related key data, comedication and health and mental condition, socioeconomic status, co-consumption) are monitored and examined using appropriate statistical methods (e.g. ANCOVA). The main hypotheses have been derived from the current state of the studies and the current state of scientific knowledge and will be tested on the basis of comparisons of the substitution groups. After completion of the survey at the end of October, all data from the questionnaires will be transferred to the SPSS statistics programme and the statistical calculations will be carried out. The data will be calculated according to the instructions given in the questionnaires. It will be checked whether diamondphin patients on average indicate a higher quality of life than methadone p	—

Measure

Time frame

A questionnaire battery consisting of the following questionnaires is available as measuring instruments: 1) SEL scales for recording quality of life (Averbeck et al., 1997), short form with 28 items, self-assessment of health-related quality of life. 2) HSCL-25 - Hopkins Symptom Checklist 25 (Petermann & Brähler, 2013), recording of symptoms of depression and anxiety (self-evaluation). 3) BBS Baseler Befindlichkeits-Skala (Hobi, 1985), 16 bipolar items on well-being (self-evaluation). 4) Oslo 3-Items Support Scale (Kilpeläinen et al., 2008). 5) Big Five Inventory (BFI-K) short version (Rammstedt & John, 2005), recording of the Big 5 personality traits. 6) Self-created sociodemographic questionnaire for the collection of personal key data. The aim of the study is to compare the different substitutes with regard to the dependent variables of the questionnaires (SEL, HSCL-25, BBS). It is calculated whether there are significant differences in the mean values of the individual substitute groups in relation to the constructs of the questionnaires. Possible influences due to the perception of social support (Oslo Support Scale), personality (BFI-K) or certain sociodemographic characteristics (age, gender, treatment-related key data, comedication and health and mental condition, socioeconomic status, co-consumption) are monitored and examined using appropriate statistical methods (e.g. ANCOVA). The main hypotheses have been derived from the current state of the studies and the current state of scientific knowledge and will be tested on the basis of comparisons of the substitution groups. After completion of the survey at the end of October, all data from the questionnaires will be transferred to the SPSS statistics programme and the statistical calculations will be carried out. The data will be calculated according to the instructions given in the questionnaires. It will be checked whether diamondphin patients on average indicate a higher quality of life than methadone p

—

Secondary

Measure	Time frame
The target criteria are the measurement of the following questionnaires: Hopkins Symptom Checklist-25 - German Version SEL scales for quality of life assessment BBS Baseler Feeling Scale	—

Countries

Austria, Germany

Contacts

Public ContactStephanie Guillery

Charité Universitätsmedizin Berlin

stephanie.guillery@charite.de01721349233

Outcome results

None listed

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