Heroin AddictionMETHODENCT02062723
Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients in a MMT
An observational study of Heroin Addiction, run by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. at 22 sites in Germany.
Trial summary
The efficacy and tolerability of Eptadone® in the context of a maintenance program will be evaluated in an observational prospective, multicenter study, in heroin addicted patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heroin Addiction
- How many people
- 515 participants
- Where
- 22 sitesGermany
- Study dates
- Sep 2010to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Male and female patients with heroin addiction, over 18 years of age.
Who may be able to join
- Both sexes
- Over 18 years of age
- Patients with a diagnosis of heroin addiction, according to ICD-10 (International Classification of Diseases-10)
- Patients who receive a "maintenance treatment" with Eptadone® since at least one month
- Accession to the observational study by informed consent
Who cannot join
- Inability to follow the observation and to understand study procedure and follow them
- Diagnosis of:
- Decompensated psychotic disorders,
- Epileptic attacks, not related with drug abuse,
- Severe-acute or severe-chronic somatic diseases (like AIDS, Tubercolosis, acute hepatitis, Sepsis ecc), whereas chronical HCV is not an exclusion criteria.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Germany22 sites
Facharzt für Allgemeinmedizin
Bad Honnef, D-53604
Praxis Turmstrasse
Berlin, D-10551
Praktischer Arzt
Bonn, D-53113
Arzt für Allgemeinmedizin
Bremen, D-28719
Psychiatrie
Bremen, D-28719
Praxis
Cologne, D-50679
Dres. Beck & Hummel Artzegemeinschaft
Fürstenfeldbruck, D- 82256
Gemeinschaftspraxis fur Neurologie, Psychiatrie und Suchtmedizin Poliklinik Silberhohe
Halle, D-06132
Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik fur Psychiatrie und Psychotherapie
Hamburg, D-20246
Arzt für Allgemeinmedizin
Hamburg, D-20357
Gemeinschaftspraxis Suchtmedizin
Hamburg, D-22143
Fachgebiet Allgemeinmedizin
Hamburg, D-22147
Praxiszentrum Friedrichsplatz
Kassel, D-34117
Facharzt für Psychiatrie Psychotherapie
Lehrte, D-31275
Facharzt für Innere Medizin
Leipzig, D-04107
Praxiszentrum im Tal
München, D-80331
Praxis
München, D-80339
Concept Schwerpunktpraxis Sucht
München, D-80801
Facharzt fur Psychiatrie
Münster, D-48147
Hausärztliche Praxis
Regensburg, D-93051
Bezirksklinik Regensburg
Regensburg, D-93053
Psychatrie
Ulm, D-89073
About this study
Official title: Prospective Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients Undergoing a Methadone Maintenance Treatment
The efficacy and tolerability of Eptadone® in the context of a maintenance program will be evaluated in an observational prospective, multicenter study, in heroin addicted patients.
Read the detailed description
515 patients have been selected among all patients addicted to heroin according ICD-10, in maintenance treatment with Eptadone, observed in the involved sites. The investigators have used the treatment schemes with Eptadone conform to the registered use.
The enrollment has been competitive. Patients met incl/excl and that have signed the informed consent have been observed for 1 year. Follow up visits have been performed according to routine procedures, for patients related to the centres at 3/6/12 months post V1. During the visits patients have been assessed by validated and used as clinical practice questionaries. Safety and tolerability have been assessed through the collection of adverse reactions and of laboratory tests.
- Conditions
- Heroin Addiction
- Keywords
- methadone, heroin addiction, methadone maintenance treatment, adequate dosage of methadone
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pts addicted to heroin in MMT | patients addicted to heroin who have undertaken methadone maintenance treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Efficacy and Tolerability of maintenance treatment with Eptadone®, in patients addicted to heroin.
Measured: From baseline to end of study (12 months after baseline)
Secondary outcomes (1)
Secondary endpoints
Pharmacoeconomic evaluation of the maintenance treatment with Eptadone®; compliance of patients to the treatment with Eptadone®; efficacy of Eptadone® in relation to sex and group of age; effects of methadone on sexual functioning.
Measured: From baseline to end of study (12 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startSep 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin AddictionStudies 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
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062723
- Sponsor's protocol ID
- MOLT-2009-002
- Acronym
- METHODE
- Status last verified
- Feb 2014
- First submitted
- 24 Jan 2014
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients Undergoing a Methadone Maintenance Treatment
- ClinicalTrials.gov ID
- NCT02062723
- Acronym / sponsor ID
- METHODE / MOLT-2009-002
- Conditions
- Heroin Addiction
- Keywords
- methadone, heroin addiction, methadone maintenance treatment, adequate dosage of methadone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy and tolerability of Eptadone® in the context of a maintenance program will be evaluated in an observational prospective, multicenter study, in heroin addicted patients.
Detailed description
515 patients have been selected among all patients addicted to heroin according ICD-10, in maintenance treatment with Eptadone, observed in the involved sites. The investigators have used the treatment schemes with Eptadone conform to the registered use.
The enrollment has been competitive. Patients met incl/excl and that have signed the informed consent have been observed for 1 year. Follow up visits have been performed according to routine procedures, for patients related to the centres at 3/6/12 months post V1. During the visits patients have been assessed by validated and used as clinical practice questionaries. Safety and tolerability have been assessed through the collection of adverse reactions and of laboratory tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pts addicted to heroin in MMT | – | –patients addicted to heroin who have undertaken methadone maintenance treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients with heroin addiction, over 18 years of age.
Key inclusion criteria (5 listed)
- Both sexes
- Over 18 years of age
- Patients with a diagnosis of heroin addiction, according to ICD-10 (International Classification of Diseases-10)
- Patients who receive a "maintenance treatment" with Eptadone® since at least one month
- Accession to the observational study by informed consent
Key exclusion criteria (5 listed)
- Inability to follow the observation and to understand study procedure and follow them
- Diagnosis of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary endpoint
Time frame: From baseline to end of study (12 months after baseline)
Efficacy and Tolerability of maintenance treatment with Eptadone®, in patients addicted to heroin.
1 secondary outcome
Secondary endpoints
Time frame: From baseline to end of study (12 months after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heroin Addiction, run by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. at 22 sites in Germany.
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 5 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 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary endpoint (time frame: From baseline to end of study (12 months after baseline)). 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 14 Feb 2014.