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| Name | Class |
|---|---|
| Solaris CRO | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pts addicted to heroin in MMT | patients addicted to heroin who have undertaken methadone maintenance treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years ( 7 visits for patient ) |
| Measure | Description | Time Frame |
|---|---|---|
| QT prolongation risk in patients addicted to heroin who have undertaken MMT | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients addicted to heroin and who have undertaken a methadone maintenance treatment, observed in involved centres.
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| Name | Affiliation | Role |
|---|---|---|
| Donatella Mariani | Solaris CRO | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento DSM, DP area Dipendenze Patologiche, UOSD Ser.T BO est | Bologna | BO | 40138 | Italy | ||
| Dipartimento delle Dipendenze ASL MI 2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23822738 | Background | 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. |
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| ID | Term |
|---|---|
| D006556 | Heroin Dependence |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| 2 years ( 7 visits for patient ) |
| pharmacoeconomic condition correlated with the adequate dosage in comparison to not adequate dosage. | 2 years ( 7 visits for patient ) |
| Milan |
| MI |
| 20063 |
| Italy |
| Servizio dipendenze, AUSL | Pescara | PE | 65124 | Italy |
| Dipartimento Dipendenze, ASL TO 2 | Torino | TO | 10149 | Italy |
| U.O.C. Ser.T ASL RMC, Distretto 11 | Roma | 00178 | Italy |
| D001523 | Mental Disorders |