Heroin AddictionMETODONCT02062736
Observational Study to Assess the Adequacy of Methadone Dosage, 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 5 sites in Italy.
Trial summary
The purpose of the study ( observational and prospective ) is to evaluate the efficacy and tolerability of the methadone maintenance treatment in patients addicted to heroin. The efficacy and tolerability are assessed by correlating to the adequacy of the dosage of methadone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heroin Addiction
- How many people
- 500 participants
- Where
- 5 sitesItaly
- Study dates
- Feb 2010to Mar 2014
- 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: patients addicted to heroin and who have undertaken a methadone maintenance treatment, observed in involved centres.
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)
- Patients who have undertaken a methadone maintenance treatment
- Adhesion to observational study by signing informed consent.
Who cannot join
- Inability to follow the observation
- Diagnosis of decompensated psychotic disorders
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Dipartimento DSM, DP area Dipendenze Patologiche, UOSD Ser.T BO est
Bologna, BO, 40138
Dipartimento delle Dipendenze ASL MI 2
Milan, MI, 20063
Servizio dipendenze, AUSL
Pescara, PE, 65124
U.O.C. Ser.T ASL RMC, Distretto 11
Roma, 00178
Dipartimento Dipendenze, ASL TO 2
Torino, TO, 10149
About this study
Official title: Studio Osservazionale Per Valutare l'Adeguatezza Del Dosaggio Del Metadone, Nelle Terapie di Mantenimento, in Rapporto Agli Obbiettivi di Outcome, in Pazienti Tossicodipendenti da Eroina. (METODO)
The purpose of the study ( observational and prospective ) is to evaluate the efficacy and tolerability of the methadone maintenance treatment in patients addicted to heroin. The efficacy and tolerability are assessed by correlating to the adequacy of the dosage of methadone. The patients will be observed for two years.
Read the detailed description
500 patients will be selected among all patients addicted to heroin according to DSM-IV_TR (Diagnostic and Statistical Manual of Mental Disorders IV_ text revision), in maintenance methadone treatment, observed in the involved sites. The investigators will use treatment schemes with methadon conform to clinical practice and according to SPC (Summary of Product Characteristics).
The enrollment will be competitive. Patients that meet incl/excl and that sign the informed consent, will be observed for 2 years. Follow up visits will be performed according to routine procedures, for patients that belong regularly to site at 3/6/9/12/18/24 months post V1. During the visits, patients will be assessed by validated and used as clinical practice questionnaires . For the evaluations of tolerability and safety the laboratory tests and electrocardiograms routinely performed will be collected.
- 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.
the efficacy of the methadone maintenance treatment in addicted heroin patients, evaluating the correlation among efficacy and adequate dosage in comparison to not adequate dosage.
Measured: 2 years ( 7 visits for patient )
Secondary outcomes (3)
QT prolongation risk in patients addicted to heroin who have undertaken MMT
Measured: 2 years ( evaluation at t0, t0 +6/12/18/24 months)
psychopathological status of observed patients in correlation with the adequate dosage in comparison to not adequate dosages
Measured: 2 years ( 7 visits for patient )
pharmacoeconomic condition correlated with the adequate dosage in comparison to not adequate dosage.
Measured: 2 years ( 7 visits for patient )
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 startFeb 2010
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 500 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)
- Collaborators
- Solaris CRO
- Responsible party
- Sponsor
- Investigators
- Donatella Mariani, Study chair, Solaris CRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062736
- Sponsor's protocol ID
- M.E.T.O.D.O.
- Acronym
- METODO
- Status last verified
- Apr 2016
- First submitted
- 24 Jan 2014
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
D'Egidio PF, Bignamini E, De Vivo E, Leonardi C, Pieri MC, Gonzalez-Saiz F, Lucchini A; METODO Study Team. METODO, a prospective observational study to assess the efficacy and tolerability of methadone in heroin-addicted patients undergoing a methadone maintenance treatment: preliminary results at baseline evaluation. Subst Use Misuse. 2013 Dec;48(14):1530-40. doi: 10.3109/10826084.2013.800886. Epub 2013 Jul 3.
PubMed 23822738
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Osservazionale Per Valutare l'Adeguatezza Del Dosaggio Del Metadone, Nelle Terapie di Mantenimento, in Rapporto Agli Obbiettivi di Outcome, in Pazienti Tossicodipendenti da Eroina. (METODO)
- ClinicalTrials.gov ID
- NCT02062736
- Acronym / sponsor ID
- METODO / M.E.T.O.D.O.
- Conditions
- Heroin Addiction
- Keywords
- methadone, heroin addiction, methadone maintenance treatment, adequate dosage of methadone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Solaris CRO
- Study start
- Feb 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (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 purpose of the study ( observational and prospective ) is to evaluate the efficacy and tolerability of the methadone maintenance treatment in patients addicted to heroin. The efficacy and tolerability are assessed by correlating to the adequacy of the dosage of methadone. The patients will be observed for two years.
Detailed description
500 patients will be selected among all patients addicted to heroin according to DSM-IV_TR (Diagnostic and Statistical Manual of Mental Disorders IV_ text revision), in maintenance methadone treatment, observed in the involved sites. The investigators will use treatment schemes with methadon conform to clinical practice and according to SPC (Summary of Product Characteristics).
The enrollment will be competitive. Patients that meet incl/excl and that sign the informed consent, will be observed for 2 years. Follow up visits will be performed according to routine procedures, for patients that belong regularly to site at 3/6/9/12/18/24 months post V1. During the visits, patients will be assessed by validated and used as clinical practice questionnaires . For the evaluations of tolerability and safety the laboratory tests and electrocardiograms routinely performed will be collected.
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
- patients addicted to heroin and who have undertaken a methadone maintenance treatment, observed in involved centres.
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)
- Patients who have undertaken a methadone maintenance treatment
- Adhesion to observational study by signing informed consent.
Key exclusion criteria (2 listed)
- Inability to follow the observation
- Diagnosis of decompensated psychotic disorders
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
the efficacy of the methadone maintenance treatment in addicted heroin patients, evaluating the correlation among efficacy and adequate dosage in comparison to not adequate dosage.
Time frame: 2 years ( 7 visits for patient )
3 secondary outcomes
QT prolongation risk in patients addicted to heroin who have undertaken MMT
Time frame: 2 years ( evaluation at t0, t0 +6/12/18/24 months)
psychopathological status of observed patients in correlation with the adequate dosage in comparison to not adequate dosages
Time frame: 2 years ( 7 visits for patient )
pharmacoeconomic condition correlated with the adequate dosage in comparison to not adequate dosage.
Time frame: 2 years ( 7 visits for patient )
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 28 Apr 2016.
- Background: PubMed 23822738D'Egidio PF, Bignamini E, De Vivo E, Leonardi C, Pieri MC, Gonzalez-Saiz F, Lucchini A; METODO Study Team. METODO, a prospective observational study to assess the efficacy and tolerability of methadone in heroin-addicted patients undergoing a methadone maintenance treatment: preliminary results at baseline evaluation. Subst Use Misuse. 2013 Dec;48(14):1530-40. doi: 10.3109/10826084.2013.800886. Epub 2013 Jul 3.
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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.
Donatella Mariani study chair
Solaris CRO
5 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 5 sites in Italy.
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 2 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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?
the efficacy of the methadone maintenance treatment in addicted heroin patients, evaluating the correlation among efficacy and adequate dosage in comparison to not adequate dosage. (time frame: 2 years ( 7 visits for patient )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02062736, which also lists 1 linked publication.
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 28 Apr 2016.