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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence or absence of co-addictions (exept tobacco dependence) | Questionnaire | 1 day |
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General Inclusion Criteria:
General non-Inclusion Criteria:
Non-Inclusion criteria for patients participating in the ancillary study:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Marie Grall-Bronnec, PH | Nantes University Hospital | Study Director |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest Universit Hospital | Brest | 29820 | France | |||
| CSAPA "La métairie" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23334576 | Background | 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. | |
| 21698341 | Background | 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. |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D009293 | Opioid-Related Disorders |
| D005715 | Gambling |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
| D012309 | Risk-Taking |
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Collecting 2 EDTA tubes of 5 mL (blood)
| La Roche-sur-Yon |
| 85000 |
| France |
| Morlaix Hospital | Morlaix | 29672 | France |
| CSAPA "Le triangle" | Nantes | 44000 | France |
| University Hospital Nantes | Nantes | 44093 | France |
| CSAPA-CAARUD "La rose des vents" | Saint-Nazaire | 44600 | France |
| Réseau toxicomanie de la région nantaise | Saint-Sébastien-sur-Loire | 44230 | France |
| 21654176 | Background | 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. |
| 39252018 | Derived | 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. |
| 35346219 | Derived | 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. |
| 33546494 | Derived | 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. |
| D001519 | Behavior |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |