Informations générales (source: ClinicalTrials.gov)
Hair Testing to Assess Consumption of Illicit Psychotropic Agents and Alcohol by Patients Treated With High-dose Buprenorphine and Methadone. Search for a Pharmacogenetic Contribution to Low Efficacy of Substitution Medications
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
août 2010
août 2015
29 juin 2024
Justification and aims of the study: The principal aim of use of opiate substitutes such
as methadone or high-dose buprenorphine (HDB) is to reduce the need or the desire to
consume the opiate to which the patient is addicted. Adjustment of the initial dose and
regular re-evaluation of the efficacy of treatment are key elements in the success of
such management. While too high a dose can be responsible for side effects leading to
abandonment of treatment, too low a dose can induce the reappearance or even the
reinforcing of parallel consumption of other psychoactive substances, in particular
cocaine, alcohol and cannabis. The principal aim of this project is to determine the
course of parallel consumption in patients who have been receiving a maintenance dose of
methadone or HDB for at least two months, by analysis of a sample of hair, a biological
matrix which is innovative for this type of study. Hair testing establishes a
retrospective profile of consumption. The secondary aims of this project are (i) to
validate the French versions of Handelsman's subjective and objective opiate withdrawal
scales and to seek a possible correlation between high scores on these scales and the
presence of parallel consumption, and (ii) to seek an association between polyconsumption
and common functional polymorphisms of metabolic enzymes of methadone and HDB.
Expected results: Hair testing, which has the particular advantage of a long detection
window so that samples need only be taken at intervals, could improve the biological
monitoring of patients on substitutive treatment.
Validation of the French version of Handelsman's scales of objective and subjective signs
of opiate withdrawal and search for any correlation with parallel consumption will enable
these scales to be used in daily practice for clinical surveillance of patients on
substitutive treatment.
If a polymorphism of a metabolic enzyme of one or other of these molecules is detected,
rapid genotyping of a simple saliva sample will be valuable in guiding the choice of
medication when deciding on a treatment strategy
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| APHM - 13005 - Marseille - France | Anne-Laure Pelissier-Alicot | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- subjects followed for opiates substitute treatment
- patients treated by HDB or methadone for at least two months
- length of hair superior to 2 centimeters
- subjects followed for opiates substitute treatment
- patients treated by HDB or methadone for at least two months
- length of hair superior to 2 centimeters
- patients treated by HDB or methadone for less than two months
- Patients with clinical signs of intolerance or opioid overdose
- opioid treatments
- neurological or psychiatric disease
- hepatic disease
- pregnancy
- patients in prison