Completion of OST - a Prospective Study

Study Overview
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Brief Summary
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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.

Official Title
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Completion of Substitution Treatment With Methadone/Levomethadone - a Prospective Study

Conditions
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Opioid Dependence

Intervention / Treatment
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* Drug: Opiate Substitution Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: opioid dependence according ICD-10 Minimum age of 18 years In OST with methadone or levomethadone Expected or planned treatment completion during the next 12 months Informed consent to participate in the study Exclusion Criteria: Patients with planned hospitalisation during the next 12 months Patients who are likely or it is save to assume that they will be incarcerated or imprisoned during the next 12 months Disability to take part in the study or follow the study conditions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OST completers<br>Patients who are likely to complete OST during the next 12 or 18 months | Drug: Opiate Substitution Treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid dependence, opiate substitution treatment, methadone, completion, termination