Clinical trial NCT01722435: Completion of OST - a Prospective Study
Official title: Completion of Substitution Treatment With Methadone/Levomethadone - a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Dependence
Keywords: opioid dependence
opiate substitution treatment
methadone
completion
termination
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Asklepios Kliniken Hamburg GmbH
name: Dr. Rainer Ullmann
name: Dr. Sibylle Quellhorst
name: Dr. Jochen Brack
name: Michael Klemperer
name: Gesine Hoeft
First posted: 2012-11-06
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Completion of OST
timeFrame: 18 months
measure: OST Drop-outs
timeFrame: 18 months
Secondary outcomes:
measure: Mean Time to Complete OST
timeFrame: 18 months
measure: Mean Time to Drop-out of OST
timeFrame: 18 months
measure: Mean Time Staying in OST
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Centre for Interdisciplinary Addiction Research of Hamburg University
name: Jens Reimer, Professor
role: PRINCIPAL_INVESTIGATOR
References: