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NCT Number: NCT02062723

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

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.

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Key information

Conditions

Heroin Addiction Chemically-Induced Disorders Heroin Dependence Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Facharzt für Allgemeinmedizin, Bad Honnef, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Primary endpoint

    Time frame: From baseline to end of study (12 months after baseline)

    Efficacy and Tolerability of maintenance treatment with Eptadone®, in patients addicted to heroin.

Secondary outcomes

  1. Secondary endpoints

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

Industry

Registry information

Official study title

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

Acronym: METHODE

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 14, 2014
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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