Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients in a MMT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients Undergoing a Methadone Maintenance Treatment

Conditions
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Heroin Addiction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pts addicted to heroin in MMT<br>patients addicted to heroin who have undertaken methadone maintenance treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint | Efficacy and Tolerability of maintenance treatment with Eptadone®, in patients addicted to heroin. | From baseline to end of study (12 months after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to end of study (12 months after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methadone, heroin addiction, methadone maintenance treatment, adequate dosage of methadone