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NCT Number: NCT01722435

Completion of OST - a Prospective Study

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opiate Substitution Treatment

Drug

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Asklepios Kliniken Hamburg GmbH
  • Dr. Jochen Brack
  • Dr. Rainer Ullmann
  • Dr. Sibylle Quellhorst
  • Gesine Hoeft
  • Michael Klemperer

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 6, 2012
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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