Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
263 participants
OBSERVATIONAL
2013-07-11
2016-07-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nantes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marie Grall-Bronnec, PH
Role: STUDY_DIRECTOR
Nantes University Hospital
Régis Bouquié, AHU
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Stéphane Bézieau, Pr
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Pierre Bodenez
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Brest
Morgane Guillou-Landréat
Role: PRINCIPAL_INVESTIGATOR
Morlaix Hospital
Bertrand Legeay
Role: PRINCIPAL_INVESTIGATOR
Medico-psychological regional service nantes University Hospital
Isabelle Martineau
Role: PRINCIPAL_INVESTIGATOR
La Métairie center care support and prevention of addiction
Philippe Levassor
Role: PRINCIPAL_INVESTIGATOR
La Rose des Vents center care support and prevention of addiction
Jean-Yves Guillet
Role: PRINCIPAL_INVESTIGATOR
General practitioners in the drug-addiction network of the Nantes Area
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brest Universit Hospital
Brest, , France
CSAPA "La métairie"
La Roche-sur-Yon, , France
Morlaix Hospital
Morlaix, , France
CSAPA "Le triangle"
Nantes, , France
University Hospital Nantes
Nantes, , France
CSAPA-CAARUD "La rose des vents"
Saint-Nazaire, , France
Réseau toxicomanie de la région nantaise
Saint-Sébastien-sur-Loire, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bouju G, Hardouin JB, Boutin C, Gorwood P, Le Bourvellec JD, Feuillet F, Venisse JL, Grall-Bronnec M. A shorter and multidimensional version of the Gambling Attitudes and Beliefs Survey (GABS-23). J Gambl Stud. 2014 Jun;30(2):349-67. doi: 10.1007/s10899-012-9356-3.
Grall-Bronnec M, Wainstein L, Feuillet F, Bouju G, Rocher B, Venisse JL, Sebille-Rivain V. Clinical profiles as a function of level and type of impulsivity in a sample group of at-risk and pathological gamblers seeking treatment. J Gambl Stud. 2012 Jun;28(2):239-52. doi: 10.1007/s10899-011-9258-9.
Grall-Bronnec M, Wainstein L, Augy J, Bouju G, Feuillet F, Venisse JL, Sebille-Rivain V. Attention deficit hyperactivity disorder among pathological and at-risk gamblers seeking treatment: a hidden disorder. Eur Addict Res. 2011;17(5):231-40. doi: 10.1159/000328628. Epub 2011 Jun 7.
Beslot A, Grall-Bronnec M, Balem M, Schreck B, Laforgue EJ, Victorri-Vigneau C, Guillou-Landreat M, Leboucher J; OPAL-Group; Challet-Bouju G, Cabelguen C. ADHD: prevalence and effect on opioid use disorder treatment outcome in a French sample of patients receiving medication for opioid use disorder-the influence of impulsivity as a mediating factor. Harm Reduct J. 2024 Sep 9;21(1):165. doi: 10.1186/s12954-024-01079-7.
Guillou Landreat M, Dany A, Challet Bouju G, Laforgue EJ, Cholet J, Leboucher J, Hardouin JB; OPAL Group; Victorri Vigneau C, Grall Bronnec M. How do people who use drugs receiving Opioid Medication Therapy perceive their treatment ? A multicentre study. Harm Reduct J. 2022 Mar 28;19(1):31. doi: 10.1186/s12954-022-00608-6.
Guillou-Landreat M, Dany A, Challet-Bouju G, Laforgue E, Leboucher J, Benoit Hardouin J, Victorri-Vigneau C, Grall-Bronnec M. What Differs between Patients under Methadone and under Buprenorphine for Opioid Use Disorder (OUD) in Daily Clinical Practice in France? A Short Report. Int J Environ Res Public Health. 2021 Feb 3;18(4):1425. doi: 10.3390/ijerph18041425.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC12_0498
Identifier Type: -
Identifier Source: org_study_id