OPAL: "Opiates and PhArmacoLogy"

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01847729
First received: April 10, 2013
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

The aim of this study is to determine the current prevalence of co-addictions, including problem/pathological gambling, in patients receiving Opiate Substitution Treatment (OST), and to then compare patients receiving OST with or without a co-addiction (excluding tobacco dependence) in order to determine their clinical profile.

In addition, an ancillary study to be carried out only among those patients receiving methadone, will aim to etablish whether a low plasma concentration of methadone, on the one hand, and an ultrarapid metabolizer genetic profile, on the other, are the characteristics most commonly associated with the presence of co-addictions. This will allow us to complete patient's pharmacological characterization.


Condition
Substance Use Disorder

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multicenter Study Assessing the Prevalence of Co-addictions in Subjects Receiving Maintenance Treatment for Opiate Dependence. Determination of Clinical and Pharmacological Profil.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Presence or absence of co-addictions (exept tobacco dependence) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Questionnaire


Biospecimen Retention:   Samples With DNA

Collecting 2 EDTA tubes of 5 mL (blood)


Estimated Enrollment: 354
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients on OST prescribed to treat opiate dependence
Collecting socio-demographic data, data concerning opiate dependence, data about other substance use disorder, data regarding gambling practice, psychopathological data.

Detailed Description:

Non-interventionel study Total duration: 12 months (preparation, recruitment, analysis) Recruitment period: 6 months Duration of monitoring per patient: no monitoring

Main objective: to assess the current prevalence of addictive co-morbidities in opiate-dependent subjects receiving Opiate Substitution Treatment (OST) for at least 6 months.

Secondary objective: to compare patients being treated using OST who currently have a co-addiction (with the exception of tobacco dependence) with patients being treated with OST who do not currently have a co-addiction, based on pharmacological and clinical characteristics (for pharmacological characteristics: pharmacokinetic and pharmacogenetic analyses as part of an ancillary study into only those patients being treated with methadone).

Main judgment criterion: Presence or absence of co-addictions (except tobacco dependence), determined using assessment tools.

The secondary assessment criteria shall be: sociodemographic data, data about opiate dependence, data about other substance use disorders, data about gambling practice, psychopathological data (impulsivity, ADHD), pharmacokinetic data and pharmacogenetic data.

Statistical analysis: For the main judgment criterion, a rate of prevalence of current co-addictions will be estimated using a 95% confidence interval.

Descriptive analyses will be carried out for all variables gathered and along with point estimates and 95% confidence intervals for qualitative and quantitative variables.

The second stage will involve univariate exploratory analyses. The two groups of patients will be compared according to the presence or absence of co-addictions. For the quantitative variables Student tests or non parametric tests will be used. For the qualitative variables, we will use Chi-squared or Fisher tests.

Finally, multivariate analyses will be carried out. The factors that have been previously identified as a being linked to co-addictions (with the threshold p = 0.2) will the be incorporated into logistic regression models. The best model, wich enables explanation of the co-addictions will then be selected using likelihood ratio tests.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study deals with patients on OST precsribed to treat opiate dependence; the OST may be methadone, buprenorphine (+/- naloxone) or a morphine-based drug.

The total group of patients to be inclued is estimated at 384 patients. Of these patients, 200 will take part in the ancillary study.

The number of recruitment centers foreseen allows this objective to be met in 6 months.

Those participating in this study will not be able to participate in another study (notably in order to avoid drug interactions).

Criteria

General Inclusion Criteria:

  • Over 18,
  • Under treatment unsing methadone or buprenorhine (+/- naloxone) or morphine as substitute, prescribed for opiate dependence,
  • OST begining at least 6 months previously,
  • Incarceration for less than a month in the event of monitoring in SMPR,
  • Good understanding of French, able to read and write.

General non-Inclusion Criteria:

  • Protected adults (guardianship, wardship)
  • Disorder of higher-order brains functions (severe cognitive disorders or confusion) or psychotic disorder (hallucinations, delusion) that may interfere with the study.

Non-Inclusion criteria for patients participating in the ancillary study:

  • Medical monitoring by a doctor from the Drug Addiction Network of the Nantes Area,
  • OST other than methadone
  • Adjustement to dosage in the 5 days prior to administering OST
  • Pregnant women
  • Absence of social security registration.
  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: NCT01847729

Contacts
Contact: Marie GRALL-BRONNEC, Doctor 02.40.84.61.16 marie.bronnec@chu-nantes.fr

Locations
France
Brest Universit Hospital Recruiting
Brest, France, 29820
Contact: Pierre Bodenez, Dr    02.98.01.50.42    pierre.bodenez@chu-brest.fr   
Principal Investigator: Pierre Bodenez, Dr         
CSAPA "La métairie" Recruiting
La Roche sur Yon, France, 85000
Contact: Isabelle Martineau, Dr    02.51.05.23.39    imartineau@la-metairie.org   
Principal Investigator: Isabelle Martineau, Dr         
Morlaix Hospital Recruiting
Morlaix, France, 29672
Contact: Morgane Guillou-Landréat, Dr    02.98.62.69.41    mguillou@ch-morlaix.fr   
Principal Investigator: Morgane Guillou-Landréat, Dr         
CSAPA "Le triangle" Recruiting
Nantes, France, 44000
Contact: Paul Bolo, Dr    02.40.48.48.58    le.triangle@wanadoo.fr   
Principal Investigator: Paul Bolo, Dr         
University Hospital Nantes Recruiting
Nantes, France, 44093
Contact: Marie Grall-Bronnec, Doctor    02 40 84 61 16    marie.bronnec@chu-nantes.fr   
Principal Investigator: Marie Grall-Bronnec, Doctor         
CSAPA-CAARUD "La rose des vents" Recruiting
Saint Nazaire, France, 44600
Contact: Philippe Levassor, Dr    02.40.01.96.12    p.levassor.larosedesvents@orange.fr   
Principal Investigator: Philippe Levassor, Dr         
Réseau toxicomanie de la région nantaise Recruiting
Sébastien sur Loire, France, 44230
Contact: Jean-Yves Guillet, Dr    02.28.01.43.18    reseau.toxicomanie@wanadoo.fr   
Principal Investigator: Jean-Yves Guillet, Dr         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Study Director: Marie Grall-Bronnec, PH Nantes University Hospital
Principal Investigator: Régis Bouquié, AHU Nantes University Hospital
Principal Investigator: Stéphane Bézieau, Pr Nantes University Hospital
Principal Investigator: Pierre Bodenez University Hospital, Brest
Principal Investigator: Morgane Guillou-Landréat Morlaix Hospital
Principal Investigator: Bertrand Legeay Medico-psychological regional service nantes University Hospital
Principal Investigator: Isabelle Martineau La Métairie center care support and prevention of addiction
Principal Investigator: Philippe Levassor La Rose des Vents center care support and prevention of addiction
Principal Investigator: Jean-Yves Guillet General practitioners in the drug-addiction network of the Nantes Area
  More Information

Publications:
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01847729     History of Changes
Other Study ID Numbers: RC12_0498
Study First Received: April 10, 2013
Last Updated: May 9, 2014
Health Authority: France: Institutional Ethical Commitee

Keywords provided by Nantes University Hospital:
pathological gambling
Opiate dependence
Opiate substitution treatment
co-addictions
Patients addicted to opiates
methadone
buprenorhine
morphine
OST in place
pharmacokinetic
pharmacogenetic
polymorphism
cytochrome P450 2D6
Therapeutic Drug Monitoring

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014