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Completion of Substitution Treatment With Methadone/Levomethadone - a Prospective Study
Sponsor study identifier
observational
78
0 countries
N/A
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Actual (reported)Study Completion
February 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 2, 2012
Actual (reported)November 6, 2012
Actual (reported)February 2014
Actual (reported)February 2014
Actual (reported)August 22, 2014
Actual (reported)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
Mean Time to Complete OST
18 months
Mean Time to Drop-out of OST
18 months
Mean Time Staying in OST
18 months
Patients who are likely to complete OST during the next 12 or 18 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients in primary care setting (GPs) or specialized clinics likely to complete opiate substitution treatment (OST) during the next 12 months.
Jens Reimer, Professor
Centre for Interdisciplinary Addiction Research of Hamburg University
78 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2012
First Posted
November 6, 2012
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2014
Actual (reported)Study Completion
February 2014
Actual (reported)Last Updated
October 9, 2019
Results First Posted
August 22, 2014
Record last verified: 2019-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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