Trial document





This trial has been registered retrospectively.
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  DRKS00000625

Trial Description

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Title

Prospective observational study to assess the efficacy and tolerability of Eptadone®,
in heroin addicted patients undergoing a methadone maintenance treatment.

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Trial Acronym

Metho.de

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Addiction is a chronic disease with a tendency to recur, characterized by compulsive use and seek for the substance, which go with biochemical, functional and structural changes in the central nervous system and that in some cases can last for a lifetime. The consequences of the use of opioids for the users fall into three categories:
I. those direct, related to use such as overdoses, and psychiatric disorders,
II. those indirect, related to intravenous use, as the exposure to the contagion of infectious diseases such as HIV, hepatitis B and C viruses and other microorganisms, and
III. those social, such as loss of employment, the deterioration of human relations, criminal activity and prostitution.
The objective of this study is to assess the efficacy and tolerability of Eptadone® (Methadone), in heroin addicted patients undergoing a methadone maintenance treatment, consistent with the registered use.
We select 420 subjects among all patients with a diagnosis of heroin addiction, who are undergoing a “maintenance treatment” with Eptadone® in the 13 centres involved.
In this observational study, the ODAS scale (Opiate Dosage Adequacy Scale) and ASI (Addiction Severity Index), will be used for the efficacy evaluation of the maintenance treatment. The ODAS scale provides a tool to assess the effectiveness of the Eptadone® in methadone maintenance treatment in heroin addicted patients. The ASI is used for assessing substance-abuse patients at the time of their admission for treatment; therefore, it provides important information about aspects of the life of patients that may contribute to their substance-abuse problems.
For the evaluation of the tolerability of treatment, the laboratory tests routinely performed will be collected.

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Brief Summary in Scientific Language

The effectiveness of “methadone maintenance treatment” (MMT) for the treatment of heroin addiction, when previous multidisciplinary interventions have not yielded positive results, has already been fully demonstrated4. Yet the first studies of Dole and Nyswander5-7 underlined the effectiveness of substitutive treatment with methadone on interruption of heroin assumption through methadone block, which must still be associated with a course of rehabilitation with adequate psychological support.
After Dole and Nyswander, many clinical studies have been carried out8-9 on methadone treatment, both experimental (randomized clinical trial, placebo-controlled, or with other drugs) and observational (retrospective and prospective cohort studies) in patients with demonstrated opioid dependence. The overall analysis of these studies shows that patients who access the MMT achieved significant improvements in terms of retention in treatment, reduction / cessation of the use of opioids, craving reduction, reduced criminal behaviour, psychological well-being and social adjustment.


In this study, 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
420 subjects will be selected among all patients with a diagnosis of heroin addiction according to ICD-10, who are undergoing a “maintenance treatment” with Eptadone® in the centres involved. They will be observed in 13 centres, with competitive enrolment. Each subject will be observed for a maximum period of 12 months in which data collected will be recorded in 4 scheduled visits.
Assessment of the effectiveness of treatment with Eptadone® will be evaluated using the following parameters:
(i) Treatment retention rate (intended as the n° of patient that will not abandon definitely the treatment) and duration of retention in treatment;
(ii) Addiction severity (Addiction Severity Index (EuropASI)
(iii) Derogatis Interview for Sexual Functioning- Self Report [DISF-SR]
(iv) Adequacy of the Eptadone®- dosage (ODAS scale)

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Organizational Data

  •   DRKS00000625
  •   2010/12/28
  •   [---]*
  •   no
  •   Approved
  •   PV3468, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   F10-F19 -  Mental and behavioural disorders due to psychoactive substance use
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Interventions/Observational Groups

  •   Patients with a diagnosis of heroin addiction according to ICD-10, who are undergoing a “maintenance treatment” with Eptadone® in the centres involved
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   [---]*
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Primary Outcome

To evaluate the efficacy and tolerability of maintenance treatment with Eptadone®, in patients addicted to heroin.
For the efficacy evaluation, the following parameters will be assessed:
(i )Treatment retention rate and duration of retention in treatment;
(ii) addiction severity (Addiction Severity Index [EuropASI]);
(iii) adequacy of the methadone dosage (ODAS scale);

The following assessments will be performed prior to and on specified days during and following the treatment:
(a) Vital signs and physical examination;
(b) Collection of any adverse reactions;
(c) Evaluation of laboratory safety parameters (complete Blood cells counts, coagulation tests, serum biochemistry tests).
Abnormal laboratory values that are considered to be clinically relevant by the Investigator must be repeated to rule out laboratory error and followed up until they have returned to normal or to a stable status, except if an adequate explanation is found.

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Secondary Outcome

a) Pharmacoeconomic evaluation of the maintenance treatment with Eptadone®;
Pharmacoeconomic assessments will be performed using the following parameters:
(i) days of hospitalization;
(ii) use of concomitant medications;
(iii) days without working.

b) Assessing the compliance of patients to the treatment with Eptadone®,
c) Assessing the efficacy of Eptadone® in relation to sex (males and females) and groups of age,
d) Analysis of effects of Methadone on sexual functioning. Derogatis Interview for Sexual Functioning- Self Report [DISF-SR]




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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2010/10/19
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

(i) Both sexes;
(ii) Over 18 years of age;
(iii) Patients with a diagnosis of heroin addiction, according to ICD-10
(iv) Patients who starts or have started a “maintenance treatment” with Eptadone®
(v) Accession to the observational study by informed consent.

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Exclusion Criteria

Patients with the following criteria will not be observed:
a) Inability to follow the observation, and to understand study procedures and follow them;
b) Diagnosis of:
(i) Decompensated psychotic disorders,
(ii) Epileptic attacks, not related with drug abuse,
(iii) Severe-acute or severe-chronic somatic diseases (like AIDS, Tubercolosis, acute hepatitis, Sepsis ecc.), whereas chronical HCV is not an exclusion criteria.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • L. Molteni & C. dei F.lli Alitti – Soc. di Esercizio S.p.A.
    • Mr.  Dr.  Ilaria  Corti 
    • Strada Statale 67
    • 50018  Scandicci
    • Italy
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    • Emmedì s.r.l. divisione Solaris CRO
    • Ms.  Dr.  Donatella  Mariani 
    • via Carlo Poma, 1
    • 20129  Milano
    • Italy
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    • Emmedì s.r.l. divisione Solaris CRO
    • Mr.  Dr.  Alessio  Casati 
    • via Carlo Poma, 1
    • 20129  Milano
    • Italy
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Sources of Monetary or Material Support

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    • L. Molteni & C. dei F.lli Alitti – Soc. di Esercizio S.p.A.
    • Strada Statale 67
    • 50018  Scandicci
    • Italy
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Status

  •   Recruiting complete, follow-up complete
  •   2013/02/24
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.