Completion of OST - a Prospective Study
NCT01722435 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78
Last updated 2019-10-09
Summary
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.
Conditions
- Opioid Dependence
Interventions
- DRUG
-
Opiate Substitution Treatment
Sponsors & Collaborators
-
Asklepios Kliniken Hamburg GmbH
collaborator OTHER -
Dr. Rainer Ullmann
collaborator UNKNOWN -
Dr. Sibylle Quellhorst
collaborator UNKNOWN -
Dr. Jochen Brack
collaborator UNKNOWN -
Michael Klemperer
collaborator UNKNOWN -
Gesine Hoeft
collaborator UNKNOWN -
Universitätsklinikum Hamburg-Eppendorf
lead OTHER
Principal Investigators
-
Jens Reimer, Professor · Centre for Interdisciplinary Addiction Research of Hamburg University
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-07-31
- Primary Completion
- 2014-02-28
- Completion
- 2014-02-28
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