Methadone dose adjustments, plasma R-methadone levels and therapeutic outcome of opioid addiction - Methadone doses and heroin dependence

• Conditions: Heroin dependence; MedDRA version: 9.1Level: SOCClassification code 10029205Term: Nervous system disorders

• Registration Number: EUCTR2008-005028-10-IT
• Lead Sponsor: niversita' di Firenze; Dipartimento di Farmacologia Preclinica e Clinica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-17
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified