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

Molteni Farmaceutici

Status: Completed

Conditions: Heroin Addiction

Study type: Observational

Funder types: Industry

Identifiers

NCT02062723

MOLT-2009-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 515 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 exclusion criteria.

Trial design

515 participants in 1 patient group

pts addicted to heroin in MMT

Description:

patients addicted to heroin who have undertaken methadone maintenance treatment