OPAL: "Opiates and PhArmacoLogy" (OPAL)

December 11, 2018 updated by: Nantes University Hospital

A Multicenter Study Assessing the Prevalence of Co-addictions in Subjects Receiving Maintenance Treatment for Opiate Dependence. Determination of Clinical and Pharmacological Profil.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

263

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29820
        • Brest Universit Hospital
      • La Roche sur Yon, France, 85000
        • CSAPA "La métairie"
      • Morlaix, France, 29672
        • Morlaix hospital
      • Nantes, France, 44000
        • CSAPA "Le triangle"
      • Nantes, France, 44093
        • University Hospital NANTES
      • Saint Nazaire, France, 44600
        • CSAPA-CAARUD "La rose des vents"
      • Saint-Sébastien-sur-Loire, France, 44230
        • Réseau toxicomanie de la région nantaise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or absence of co-addictions (exept tobacco dependence)
Time Frame: 1 day
Questionnaire
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Stéphane Bézieau, Pr, Nantes University Hospital
  • Study Director: Marie Grall-Bronnec, PH, Nantes University Hospital
  • Principal Investigator: Régis Bouquié, AHU, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2013

Primary Completion (Actual)

July 21, 2016

Study Completion (Actual)

July 21, 2016

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_0498

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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