Comparative on mental and physical well-being and impairment in opioid dependent patients undergoing substitution treatment with methadone, buprenorphine and diamorphine.
Organizational Data
- DRKS-ID:
- DRKS00017644
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2019-09-02
- Last update in DRKS:
- 2020-12-01
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
In Germany, approximately 90,000 opioid-dependent patients are currently treated with so-called substitution therapy. This is a damage-minimizing treatment for mostly heroin-dependent patients with substitutes such as methadone, levomethadone, buprenorphine, morphine, diamorphine and other opioids. The present study is a multi-center cross-sectional survey of substituted patients using an anonymous and voluntary self-evaluation questionnaire on the subject of health-related quality of life, symptoms of anxiety and depression, psychological impairment, and sociodemographic characteristics of the sample. Opioid-dependent patients in substitution-assisted treatment from currently 11 different outpatient departments and practices in Germany and Austria are recruited by the practice staff and can fill out the questionnaire anonymously on a voluntary basis. The purpose of the survey is to compare the substitution drugs methadone/levomethadone, buprenorphine, morphine and diamorphine with respect to the above variables and to present and compare the samples on the basis of sociodemographic characteristics such as age, gender, comorbidities, therapeutic aspects, social support and personality. The aim of the study is to find possible differences and advantages and disadvantages of different substitutes and to investigate the influence of other characteristics on the quality of life of patients using statistically appropriate methods. The ethics committee of the Medical School Berlin has approved the ethics. Address: Ethics Commission Medical School Berlin Calandrellistraße 1-9, 12247 Berlin, Germany Chair: Prof. Dr. med. habil. Diethelm Hansen E-mail: diethelm.hansen@medicalschool-berlin.de
Brief summary in scientific language
The present study is a non-randomized, naturalistic cross-sectional analysis of opioid-dependent patients in substitution. The independent variable "Substitute" has 4 groups (1) methadone/levomethadone, 2) buprenorphine, 3) morphine and 4) diamorphine). It is assumed that there are about 250 volunteers per group. The dependent variables are health-related quality of life, symptoms of anxiety and depression, as well as psychological well-being. This is a four-arm study design of independent experimental groups without a control group, which is recorded in a field study using a self-evaluation questionnaire. It is measured in cross-section at one time of measurement. The main hypotheses are 1) that diamorphine patients have a significantly higher quality of life than methadone patients and 2) that diamorphine patients report significantly fewer symptoms of depression than methadone patients. Further calculations are performed on the basis of the data obtained using appropriate statistical methods (ANCOVA, Chi-Square test and others). Based on the results of existing studies showing a superiority of diamorphine over methadone in terms of health and social development and co-consumption of illicit drugs, the drugs in the current study will be investigated in terms of important constructs of quality of life.
Health condition or problem studied
- ICD10:
- F11.2
- ICD10:
- F11.0
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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 addiction clinic in Germany or Austria.
- Arm 2:
- Patients between 18 and 80 years of age who have been treated with the drug buprenorphine for at least 6 months in substitution treatment in a GP's practice or an outpatient addiction clinic in Germany or Austria.
- Arm 3:
- Patients between 18 and 80 years of age who have been treated with the drug morphine extended-release for at least 6 months in substitution treatment in a GP's practice or an outpatient addiction clinic in Germany.
- Arm 4:
- Patients between 18 and 80 years of age who have been treated with the drug diamorphine for at least 6 months in substitution treatment in a GP's practice or an outpatient addiction clinic in Germany or Austria.
Endpoints
- Primary outcome:
- 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 patients (SEL). Furthermore, it is examined whether diamorphine patients reported a lower degree of symptoms of anxiety and depression than methadone patients (HSCL-25). It is also examined whether diamorphine patients reported a more positive state of health than methadone patients. These comparisons are also made with the other substitute groups (buprenorphine, morphine).
- Secondary outcome:
- 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
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Diamorphinambulanz Altona Hamburg
- Medical center Diamorphinambulanz Stuttgart Stuttgart
- Medical center Diamorphinambulanz Köln Köln
- Medical center Diamorphinambulanz Krlsruhe Karlsruhe
- Medical center Diamorphinambulanz Düsseldorf Düsseldorf
- Other Caritas Spandau Berlin
- Medical center Diamorphinambulanz Altona Hamburg
- Medical center Diamorphinambulanz Stuttgart Stuttgart
- Medical center Diamorphinambulanz Köln Köln
- Medical center Diamorphinambulanz Krlsruhe Karlsruhe
- Other AID Neukölln Berlin
- Medical center Diamorphinambulanz Düsseldorf Düsseldorf
- Other Caritas Spandau Berlin
- Other Caritas München
- Medical center Christian Doppler Klinik Salzburg
- Medical center Diamorphinambulanz München
- Other Prop EV München
- Doctor's practice Berlin Kaiserdamm
- Medical center Patrida Diamorphinambulanz Berlin
- Medical center Dr. Naumann Berlin
Recruitment period and number of participants
- Planned study start date:
- 2019-09-02
- Actual study start date:
- 2019-07-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2020-04-01
- Target Sample Size:
- 1000
- Final Sample Size:
- 545
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 99 Years
- Additional 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
1) shorter than 6 months in substitution treatment with the current substitute 2) under 18 years of age
Addresses
Primary Sponsor
- Address:
- Charité Campus Charité MitteStephanie GuilleryCharitéplatz 110117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.charite.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Charité Universitätsmedizin BerlinStephanie GuilleryChariteplatz 110827 BerlinGermany
- Telephone:
- 01721349233
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Charité Universitätsmedizin BerlinStephanie GuilleryChariteplatz 110117 BerlinGermany
- Telephone:
- 01721349233
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Charité Universitätsmedizin BerlinStephanie GuilleryChariteplatz 110827 BerlinGermany
- Telephone:
- 01721349233
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Feurigstraße 2610827 BerlinGermany
- Telephone:
- 01721349233
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission Medical School Berlin [1)Ethikkommission Medical School Berlin 2) Ethikkommission Ludwig-Maximilian-Universität München 19-740 (13.09.2019) (Für die Studie liegen 2 Ethikvoti aus den benannten Ethikkommissionen vor)]Professor Diethelm HansenRüdesheimer Straße 5014197 BerlinGermany
- Telephone:
- 030 7668375600
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medicalschool-berlin.de/forschung/qualitaetssicherung/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-02-23
- Ethics committee number:
- MSB-2019/6
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-03-25
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry