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| Name | Class |
|---|---|
| Asklepios Kliniken Hamburg GmbH | OTHER |
| Dr. Rainer Ullmann | UNKNOWN |
| Dr. Sibylle Quellhorst | UNKNOWN |
| Dr. Jochen Brack |
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Only limited information on the process of completing long-term opiate substitution treatment (OST) with substances like methadone exist. Furthermore, systematic knowledge from scientific studies is scarce, there are only few studies with respect to treatment completion or regular termination (mainly catamnestic analyses). Studies by Nordt et al. (2004) or Nordt & Stohler (2006) show an estimated rate of 10% of patients per year who terminate OST by means of tapering the substitution agent or changing into withdrawal treatment in specialized clinics. It is state of the art that an indication for termination of OST has to be based on a common agreement between the patient and the doctor. Furthermore, the patient should live in a stable social situation and the state of health had markedly improved. Finally, the patient has to be free of (illegal) drug use for at least 6 months and the individual aims of treatment should have been reached (Vader et al. 2003).
The main objective of the prospective and explorative study is the systematic description of the process of termination of OST. With a comparison between patients who complete OST regularly and patients who terminate treatment prematurely (or are still in treatment) predictors of positive termination of OST can be identified.
Patients treated with methadone or levomethadone of 5 general practitioners' practices and 2 specialized clinics who might be able to terminate OST during the next 12 months from the doctors' perspective can take part in the study. In addition to baseline examination further assessments take place every 3 months (i.e. after 3, 6, 9 and 12 months). The questionnaires include state of health, well-being, social situation as well as drug and alcohol use. Furthermore, the treating doctors are asked every 3 months to fill out questionnaires on infections and other disorders, clinical characteristics, dosage process and drug use (measured by urine samples).
Patients who will be successful in completing OST during the observational period will be compared with the remaining cases.
Finally, a 6-month follow-up is planned in order to investigate the stability and maintenance of the situation at month 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OST completers | Patients who are likely to complete OST during the next 12 or 18 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opiate Substitution Treatment | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of OST | Regularly completion of OST, i.e. not being on opioid medication any more, during the study period. | 18 months |
| OST Drop-outs | Participants dropped out of OST Treatment during the study period. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time to Complete OST | Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months). | 18 months |
| Mean Time to Drop-out of OST | Mean time of study participation (M, SD) until drop-out of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in primary care setting (GPs) or specialized clinics likely to complete opiate substitution treatment (OST) during the next 12 months.
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| Name | Affiliation | Role |
|---|---|---|
| Jens Reimer, Professor | Centre for Interdisciplinary Addiction Research of Hamburg University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | OST Completers | Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients treated with methadone or levomethadone who were eligible for the study and consented to participate and qualified for treatment completion in the next 12 months.
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| ID | Title | Description |
|---|---|---|
| BG000 | OST Completers | The main objective of this prospective study was the description of the process of termination of opiate substitution treatment (OST). Patients in primary care setting (GPs) or specialized clinics likely to complete OST during the next 12 months were asked to fill out questionnaires every 3 months over a 12-months period and were followed up another 6 months later. Accordingly, the doctors documented their patients' state of health and provided an evaluation of their living situation every 3 months and at the end of treatment (or - if patients stayed in treatment - at the end of the 18-months study period). At the beginning of the study overall 1367 OST patients were treated in the 7 participating clinics and practices. 972 of them were treated with methadone or levomethadone. In line with the inclusion criteria, 97 patients were eligible for the study, 78 of them consented to participate in the study (8.0% of all patients treated with methadone or levomethadone). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Completion of OST | Regularly completion of OST, i.e. not being on opioid medication any more, during the study period. | Posted | Number | participants | 18 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OST Completers | Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Jens reimer | Centre for Interdisciplinary Addiction research of Hamburg University ZIS | +4940741057900 | reimer@uke.de |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D058850 | Opiate Substitution Treatment |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| UNKNOWN |
| Michael Klemperer | UNKNOWN |
| Gesine Hoeft | UNKNOWN |
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| 18 months |
| Mean Time Staying in OST | Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months). | 18 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Lengths of OST before study entry | Mean | Standard Deviation | months |
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| Participants on specific medication | Number | participants |
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| Average dose of medication taken | Mean | Standard Deviation | milligrams |
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| Primary | OST Drop-outs | Participants dropped out of OST Treatment during the study period. | Posted | Number | participants | 18 months |
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| Secondary | Mean Time to Complete OST | Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months). | Posted | Mean | Standard Deviation | days | 18 months |
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| Secondary | Mean Time to Drop-out of OST | Mean time of study participation (M, SD) until drop-out of treatment. | Posted | Mean | Standard Deviation | days | 18 months |
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| Secondary | Mean Time Staying in OST | Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months). | Posted | Mean | Standard Deviation | days | 18 months |
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| 0 |
| 78 |
| 0 |
| 78 |
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