NCT01722435

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

Completed Results posted Last updated 1 October 2019

What this trial tests

trial testing Opiate Substitution Treatment in Opioid Dependence in 78 participants. Completed in 1 February 2014.

Timeline

1 July 2011

Primary endpoint
1 February 2014

1 February 2014

Quick facts

Lead sponsor	Universitätsklinikum Hamburg-Eppendorf
Status	Completed
Study type	OBSERVATIONAL
Enrollment	78
Start date	1 July 2011
Primary completion	1 February 2014
Estimated completion	1 February 2014

Drugs / interventions tested

• Opiate Substitution Treatment — full drug profile →

Conditions studied

• Opioid Dependence — all drugs for Opioid Dependence →

Sponsor

Universitätsklinikum Hamburg-Eppendorf — full company profile →

Who can join

18 and older, any sex, with Opioid Dependence. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.