Opioid DependenceNCT01722435
Completion of OST - a Prospective Study
An observational study of Opioid Dependence, run by Universitätsklinikum Hamburg-Eppendorf.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Opiate Substitution Treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Feb 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in primary care setting (GPs) or specialized clinics likely to complete opiate substitution treatment (OST) during the next 12 months.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Completion of Substitution Treatment With Methadone/Levomethadone - a Prospective Study
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.
Read more
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
- Being tested
- Opiate Substitution Treatment
- Keywords
- opioid dependence, opiate substitution treatment, methadone, completion, termination
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opiate Substitution TreatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| OST completers | Patients who are likely to complete OST during the next 12 or 18 months Receives: Drug: Opiate Substitution Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of OST
Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.
Measured: 18 months
OST Drop-outs
Participants dropped out of OST Treatment during the study period.
Measured: 18 months
Secondary outcomes (3)
Mean Time to Complete OST
Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).
Measured: 18 months
Mean Time to Drop-out of OST
Mean time of study participation (M, SD) until drop-out of treatment.
Measured: 18 months
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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startJul 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Asklepios Kliniken Hamburg GmbH, Dr. Rainer Ullmann, Dr. Sibylle Quellhorst, Dr. Jochen Brack, Michael Klemperer, Gesine Hoeft
- Responsible party
- Principal investigator, Prof. Dr. med. Jens Reimer, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Jens Reimer, Professor, Principal investigator, Centre for Interdisciplinary Addiction Research of Hamburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722435
- Sponsor's protocol ID
- ZIS-OST-PV3718
- Status last verified
- Oct 2019
- First submitted
- 2 Nov 2012
- Last updated
- 9 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Completion of Substitution Treatment With Methadone/Levomethadone - a Prospective Study
- ClinicalTrials.gov ID
- NCT01722435
- Acronym / sponsor ID
- ZIS-OST-PV3718
- Conditions
- Opioid Dependence
- Keywords
- opioid dependence, opiate substitution treatment, methadone, completion, termination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Asklepios Kliniken Hamburg GmbH, Dr. Rainer Ullmann, Dr. Sibylle Quellhorst, Dr. Jochen Brack, Michael Klemperer, Gesine Hoeft
- Study start
- Jul 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Posted 22 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OST completers | – | Drug: Opiate Substitution TreatmentPatients who are likely to complete OST during the next 12 or 18 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in primary care setting (GPs) or specialized clinics likely to complete opiate substitution treatment (OST) during the next 12 months.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opiate Substitution Treatment | Drug | OST completers |
Primary outcome
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.
3 secondary outcomes
Mean Time to Complete OST
Time frame: 18 months
Mean Time to Drop-out of OST
Time frame: 18 months
Mean Time Staying in OST
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Reimer, Professor principal investigator
Centre for Interdisciplinary Addiction Research of Hamburg University
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Dependence, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of OST (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019; AzTrials last refreshed its copy on 30 Oct 2026.