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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02062723

Acronym

METHODE

Enrollment

515

Registered

2014-02-14

Start date

2010-09-30

Completion date

2013-02-28

Last updated

2014-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heroin Addiction

Keywords

methadone, heroin addiction, methadone maintenance treatment, adequate dosage of methadone

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Secondary endpoints	From baseline to end of study (12 months after baseline)	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.

Countries

Germany

Outcome results