Prospective observational study to assess the efficacy and tolerability of Eptadone®, in heroin addicted patients undergoing a methadone maintenance treatment.
- Conditions
- F10-F19Mental and behavioural disorders due to psychoactive substance use
- Registration Number
- DRKS00000625
- Lead Sponsor
- . Molteni & C. dei F.lli Alitti – Soc. di Esercizio S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 516
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.
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy and tolerability of maintenance treatment with Eptadone®, in patients addicted to heroin. <br>For the efficacy evaluation, the following parameters will be assessed: <br>(i )Treatment retention rate and duration of retention in treatment;<br>(ii) addiction severity (Addiction Severity Index [EuropASI]);<br>(iii) adequacy of the methadone dosage (ODAS scale);<br><br>The following assessments will be performed prior to and on specified days during and following the treatment:<br>(a) Vital signs and physical examination; <br>(b) Collection of any adverse reactions;<br>(c) Evaluation of laboratory safety parameters (complete Blood cells counts, coagulation tests, serum biochemistry tests).<br>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.<br>
- Secondary Outcome Measures
Name Time Method a) Pharmacoeconomic evaluation of the maintenance treatment with Eptadone®;<br>Pharmacoeconomic assessments will be performed using the following parameters:<br>(i) days of hospitalization;<br>(ii) use of concomitant medications;<br>(iii) days without working.<br><br>b) Assessing the compliance of patients to the treatment with Eptadone®,<br>c) Assessing the efficacy of Eptadone® in relation to sex (males and females) and groups of age,<br>d) Analysis of effects of Methadone on sexual functioning. Derogatis Interview for Sexual Functioning- Self Report [DISF-SR]<br><br><br><br><br>