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Completion of OST - a Prospective Study

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ClinicalTrials.gov Identifier: NCT01722435
Recruitment Status : Completed
First Posted : November 6, 2012
Results First Posted : August 22, 2014
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Asklepios Kliniken Hamburg GmbH
Dr. Rainer Ullmann
Dr. Sibylle Quellhorst
Dr. Jochen Brack
Michael Klemperer
Gesine Hoeft
Information provided by (Responsible Party):
Prof. Dr. med. Jens Reimer, Universitätsklinikum Hamburg-Eppendorf

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Opioid Dependence Drug: Opiate Substitution Treatment

Study Design
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Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Completion of Substitution Treatment With Methadone/Levomethadone - a Prospective Study
Study Start Date : July 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
OST completers
Patients who are likely to complete OST during the next 12 or 18 months
 Drug: Opiate Substitution Treatment


Outcome Measures
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Primary Outcome Measures :
  1. Completion of OST [ Time Frame: 18 months ]
    Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.

  2. OST Drop-outs [ Time Frame: 18 months ]
    Participants dropped out of OST Treatment during the study period.


Secondary Outcome Measures :
  1. Mean Time to Complete OST [ Time Frame: 18 months ]
    Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).

  2. Mean Time to Drop-out of OST [ Time Frame: 18 months ]
    Mean time of study participation (M, SD) until drop-out of treatment.

  3. Mean Time Staying in OST [ Time Frame: 18 months ]
    Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in primary care setting (GPs) or specialized clinics likely to complete opiate substitution treatment (OST) during the next 12 months.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722435


Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Asklepios Kliniken Hamburg GmbH
Dr. Rainer Ullmann
Dr. Sibylle Quellhorst
Dr. Jochen Brack
Michael Klemperer
Gesine Hoeft
Investigators
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Principal Investigator: Jens Reimer, Professor Centre for Interdisciplinary Addiction Research of Hamburg University
More Information
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Layout table for additonal information
Responsible Party: Prof. Dr. med. Jens Reimer, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01722435    
Other Study ID Numbers: ZIS-OST-PV3718
First Posted: November 6, 2012    Key Record Dates
Results First Posted: August 22, 2014
Last Update Posted: October 9, 2019
Last Verified: October 2019
Keywords provided by Prof. Dr. med. Jens Reimer, Universitätsklinikum Hamburg-Eppendorf:
opioid dependence
opiate substitution treatment
methadone
completion
termination
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Opiate Alkaloids
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents