Completion of OST - a Prospective Study

NCT01722435 | Completed Results

• 1 other identifier: ZIS-OST-PV3718
• Study Type: observational
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Dependence

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Completion of OST

  Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.

  18 months

• OST Drop-outs

  Participants dropped out of OST Treatment during the study period.

  18 months

Secondary Outcomes (3)

• Mean Time to Complete OST

  18 months

• Mean Time to Drop-out of OST

  18 months

• Mean Time Staying in OST

  18 months

Study Arms (1)

OST completers

Patients who are likely to complete OST during the next 12 or 18 months

Drug: Opiate Substitution Treatment

Interventions

Opiate Substitution Treatment DRUG

OST completers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Asklepios Kliniken Hamburg GmbH: collaborator
• Dr. Rainer Ullmann: collaborator
• Dr. Sibylle Quellhorst: collaborator
• Dr. Jochen Brack: collaborator
• Michael Klemperer: collaborator
• Gesine Hoeft: collaborator

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Opiate Substitution Treatment

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Prof. Dr. Jens reimer
• Organization: Centre for Interdisciplinary Addiction research of Hamburg University ZIS

reimer@uke.de

+4940741057900

Study Officials

• Jens Reimer, Professor

  Centre for Interdisciplinary Addiction Research of Hamburg University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: July 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 9, 2019
• Results First Posted: August 22, 2014

Record last verified: 2019-10