Completion of OST - a Prospective Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01722435

Enrollment

Registered

2012-11-06

Start date

2011-07-31

Completion date

2014-02-28

Last updated

2019-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Dependence

Keywords

opioid dependence, opiate substitution treatment, methadone, completion, termination

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.

Interventions

DRUGOpiate Substitution Treatment

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Completion of OST	18 months	Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.
OST Drop-outs	18 months	Participants dropped out of OST Treatment during the study period.

Secondary

Measure	Time frame	Description
Mean Time to Complete OST	18 months	Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).
Mean Time to Drop-out of OST	18 months	Mean time of study participation (M, SD) until drop-out of treatment.
Mean Time Staying in OST	18 months	Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months).

Participant flow

Participants by arm

Arm	Count
OST Completers The main objective of this prospective study was the description of the process of termination of opiate substitution treatment (OST). Patients in primary care setting (GPs) or specialized clinics likely to complete OST during the next 12 months were asked to fill out questionnaires every 3 months over a 12-months period and were followed up another 6 months later. Accordingly, the doctors documented their patients' state of health and provided an evaluation of their living situation every 3 months and at the end of treatment (or - if patients stayed in treatment - at the end of the 18-months study period). At the beginning of the study overall 1367 OST patients were treated in the 7 participating clinics and practices. 972 of them were treated with methadone or levomethadone. In line with the inclusion criteria, 97 patients were eligible for the study, 78 of them consented to participate in the study (8.0% of all patients treated with methadone or levomethadone).	78
Total	78

Arm

Count

OST Completers

The main objective of this prospective study was the description of the process of termination of opiate substitution treatment (OST). Patients in primary care setting (GPs) or specialized clinics likely to complete OST during the next 12 months were asked to fill out questionnaires every 3 months over a 12-months period and were followed up another 6 months later. Accordingly, the doctors documented their patients' state of health and provided an evaluation of their living situation every 3 months and at the end of treatment (or - if patients stayed in treatment - at the end of the 18-months study period). At the beginning of the study overall 1367 OST patients were treated in the 7 participating clinics and practices. 972 of them were treated with methadone or levomethadone. In line with the inclusion criteria, 97 patients were eligible for the study, 78 of them consented to participate in the study (8.0% of all patients treated with methadone or levomethadone).

Total

Baseline characteristics

Characteristic	OST Completers
Age, Continuous	39.5 years STANDARD_DEVIATION 7.9
Average dose of medication taken buprenorphine	14.3 milligrams STANDARD_DEVIATION 8.2
Average dose of medication taken d,l-methadone	54.8 milligrams STANDARD_DEVIATION 41.8
Average dose of medication taken levomethadone	26.6 milligrams STANDARD_DEVIATION 21.6
Lengths of OST before study entry	92.9 months STANDARD_DEVIATION 59.5
Participants on specific medication buprenorphine	4 participants
Participants on specific medication d,l-methadone	37 participants
Participants on specific medication levometahdone	37 participants
Sex: Female, Male Female	54 Participants
Sex: Female, Male Male	24 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 78
serious Total, serious adverse events	0 / 78

Outcome results

Primary