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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01285856
First received: July 29, 2010
Last updated: February 2, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention
Substance Abuse
Other: hair and saliva samples

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Hair ANALYSIS [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Hair testing which has the particular advantage of a long detection window so that samples need only be taken at intervals


Secondary Outcome Measures:
  • Validation of the French version of Handelsman's scales [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.

  • polymorphism of a metabolic enzyme [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 220
Study Start Date: August 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: buprenorphine
populations of patients treated with HDB will be recruited during consultations at a center for addiction treatment. One hundred and ten patients will be included. Written informed consent will be obtained from each patient. Anonymity will be respected at inclusion and throughout. Using a sample of hair, testing for and measurement of the principal drugs (opiates, cannabis, cocaine, amphetamines) and the specific marker of ethanol consumption, ethyl glucuronide, will be performed by chromatographic techniques (high-performance liquid chromatography and gas phase chromatography) together with detection by mass or tandem mass spectrometry. Treatment efficacy will also be assessed using Handelsman's subjective and objective opiate withdrawal scales. Lastly, polymorphisms of the metabolic enzymes of methadone and HDB will be sought by real-time PCR in a saliva sample, a method which gives similar results without the need for venous blood sampling.
Other: hair and saliva samples

Using a sample of hair, testing for and measurement of the principal drugs (opiates, cannabis, cocaine, amphetamines) and the specific marker of ethanol consumption, ethyl glucuronide, will be performed by chromatographic techniques (high-performance liquid chromatography and gas phase chromatography) together with detection by mass or tandem mass spectrometry. This non-invasive sampling is more informative than blood tests, as it gives a retrospective profile of an individual's consumption over several months.

Saliva sample, a method which gives similar results without the need for venous blood sampling.

Active Comparator: methadone
populations of patients treated with methadone will be recruited during consultations at a center for addiction treatment. One hundred and ten patients will be included. Written informed consent will be obtained from each patient. Anonymity will be respected at inclusion and throughout. Using a sample of hair, testing for and measurement of the principal drugs (opiates, cannabis, cocaine, amphetamines) and the specific marker of ethanol consumption, ethyl glucuronide, will be performed by chromatographic techniques (high-performance liquid chromatography and gas phase chromatography) together with detection by mass or tandem mass spectrometry. Treatment efficacy will also be assessed using Handelsman's subjective and objective opiate withdrawal scales. Lastly, polymorphisms of the metabolic enzymes of methadone and HDB will be sought by real-time PCR in a saliva sample, a method which gives similar results without the need for venous blood sampling.
Other: hair and saliva samples

Using a sample of hair, testing for and measurement of the principal drugs (opiates, cannabis, cocaine, amphetamines) and the specific marker of ethanol consumption, ethyl glucuronide, will be performed by chromatographic techniques (high-performance liquid chromatography and gas phase chromatography) together with detection by mass or tandem mass spectrometry. This non-invasive sampling is more informative than blood tests, as it gives a retrospective profile of an individual's consumption over several months.

Saliva sample, a method which gives similar results without the need for venous blood sampling.


Detailed Description:

Methodology: The two populations of patients, one treated with methadone, the other with HDB, will be recruited in accordance with the ethical principles of the declaration of Helsinki, during consultations at a center for addiction treatment. One hundred and ten patients will be included in each of the two populations. Written informed consent will be obtained from each patient. Anonymity will be respected at inclusion and throughout. Using a sample of hair, testing for and measurement of the principal drugs (opiates, cannabis, cocaine, amphetamines) and the specific marker of ethanol consumption, ethyl glucuronide, will be performed by chromatographic techniques (high-performance liquid chromatography and gas phase chromatography) together with detection by mass or tandem mass spectrometry. This non-invasive sampling is more informative than blood tests, as it gives a retrospective profile of an individual's consumption over several months. Treatment efficacy will also be assessed using Handelsman's subjective and objective opiate withdrawal scales. Lastly, polymorphisms of the metabolic enzymes of methadone and HDB will be sought by real-time PCR in a saliva sample, a method which gives similar results without the need for venous blood sampling.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285856

Contacts
Contact: Anne Laure Pelissier-Alicot +33491384748 anne-laure.pelissier@ap-hm.fr

Locations
France
APHM Recruiting
Marseille, France, 13005
Contact: Anne-Laure Pelissier-Alicot    +33491384748      
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Anne-Laure Pelissier-Alicot APHM
  More Information

No publications provided

Responsible Party: APHM
ClinicalTrials.gov Identifier: NCT01285856     History of Changes
Other Study ID Numbers: 2010-A00256-33, 2010-A00256-33
Study First Received: July 29, 2010
Last Updated: February 2, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
patients
illicit consumption of psychotropic agents and alcohol
buprenorphine
methadone

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Methadone
Psychotropic Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 31, 2014