Completion of OST - a Prospective Study

Opioid Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722435
• Other study ID #: ZIS-OST-PV3718
• Status: Completed
• Start date: July 2011
• Est. completion date: February 2014

Study information

• Verified date: October 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Opiate Substitution Treatment

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Asklepios Kliniken Hamburg GmbH, Dr. Jochen Brack, Dr. Rainer Ullmann, Dr. Sibylle Quellhorst, Gesine Hoeft, Michael Klemperer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of OST	Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.	18 months
Primary	OST Drop-outs	Participants dropped out of OST Treatment during the study period.	18 months
Secondary	Mean Time to Complete OST	Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).	18 months
Secondary	Mean Time to Drop-out of OST	Mean time of study participation (M, SD) until drop-out of treatment.	18 months
Secondary	Mean Time Staying in OST	Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months).	18 months