OPAL: "Opiates and PhArmacoLogy" (OPAL)
|ClinicalTrials.gov Identifier: NCT01847729|
Recruitment Status : Active, not recruiting
First Posted : May 7, 2013
Last Update Posted : August 11, 2017
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 or disease|
|Substance Use Disorder|
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|
|Actual Enrollment :||263 participants|
|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.|
|Actual Study Start Date :||July 11, 2013|
|Actual Primary Completion Date :||July 21, 2016|
|Estimated Study Completion Date :||December 31, 2017|
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.
- Presence or absence of co-addictions (exept tobacco dependence) [ Time Frame: 1 day ]Questionnaire
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847729
|Brest Universit Hospital|
|Brest, France, 29820|
|CSAPA "La métairie"|
|La Roche sur Yon, France, 85000|
|Morlaix, France, 29672|
|CSAPA "Le triangle"|
|Nantes, France, 44000|
|University Hospital Nantes|
|Nantes, France, 44093|
|CSAPA-CAARUD "La rose des vents"|
|Saint Nazaire, France, 44600|
|Réseau toxicomanie de la région nantaise|
|Sébastien sur Loire, France, 44230|
|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|