Heroin dependence MedDRA version: 9.1 Level: SOC Classification code 10029205 Term: Nervous system disorders
Conditions
Interventions
Trade Name: METADONE CL.AFOM
Pharmaceutical Form: Oral solution
INN or Proposed INN: Methadone
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 1-
Sponsors
Universita' di Firenze; Dipartimento di Farmacologia Preclinica e Clinica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients are heroin addicts aged 21-55 years requiring admission to a methadone maintenance treatment in the existing services for drug addicts (SERT) or in the Toxicology Unit, Florence University and Careggi Hospital. Pregnant women will also be included. The following are the other inclusion criteria: 1) opioid dependence lasting at least 3 years 2) more than 3 documented previous attempts to reach an opioid-free state 3) negative HIV test; 4) non obvious perception disorders 5) fluency in Italian and ability of reasonably fill up the opioid addiction treatment forms (see: annex); 6) residency in the larger Florence area (this in order avoiding enrolment of patients that will be forced to abandon the therapeutic program because of family reason or enforcement of immigration law. The following are the exclusion criteria 1) age outside the range 21-55 years 2) recent heroin dependence (dating less than 3 years with no previous attempts of achieving a drug-free state). 3) Schizophrenia 4) Positive HIV test 5) Liver Cirrhosis 6) Cancer 7) Heart failure 8) Inability to understand the aim and the conduct of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following are the exclusion criteria 1) age outside the range 21-55 years 2) recent heroin dependence (dating less than 3 years with no previous attempts of achieving a drug-free state). 3) Schizophrenia 4) Positive HIV test 5) Liver Cirrhosis 6) Cancer 7) Heart failure 8) Inability to understand the aim and the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of the present study is to improve the therapeutic outcome of opioid addicts by rationally adjusting the oral daily dose of methadone so that their plasma concentrations of the active enantiomer (R-methadone) will remain in the ?optimal range?. In order to reach the goal, patients will be divided in two groups: the first will have a standard treatment while patients in the second group will have the dose of oral methadone increased or decreased in accord to the concentration of the active enantiomer in their plasma. The ?therapeutic outcome? will be evaluated by counting the number of patients that will regularly remain in treatment for 12 months. Furthermore, each patient will have the urine checked at least once a week to evaluate the abuse of illicit drugs (heroin, cocaine, amphetamines, THC) and after six and twelve months in treatment all the patients will fill up the ?opiate treatment index form?.;Secondary Objective: A secondary objective of the study is the identification and characterization of the patients in which elevated methadone doses (up to 2 mg/kg/day) result in plasma concentrations of the active enatiomer significantly lower than 100 ng/ml. These patients will have clinical assessment and genotypic characterization of the main methadone metabolising enzymes (CYP3A4 and CYP2D6) and will be considered for different opioid agonist treatments.;Primary end point(s): We will evaluate: 1) the percentage of patients remaining in treatment after 12 months of adjusted daily methadone dose; 2) the number of urines containing illicit drugs (morphine, cocaine, amphetamines THC) 3) the number of opioid overdoses and other deaths. The procedure will be considered succesful if one or all of these measurements will be positively modified | — |
Countries
Italy
Outcome results
None listed