Clinical trial NCT01847729: OPAL: "Opiates and PhArmacoLogy"
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Use Disorder
Keywords: Opiate dependence
Opiate substitution treatment
co-addictions
Patients addicted to opiates
methadone
buprenorhine
morphine
OST in place
pathological gambling
pharmacokinetic
pharmacogenetic
polymorphism
cytochrome P450 2D6
Therapeutic Drug Monitoring
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

Brief summary: 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.

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 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.

Primary outcomes:
measure: Presence or absence of co-addictions (exept tobacco dependence)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest Universit Hospital
city: La Roche sur Yon
country: France
facility: CSAPA "La métairie"
city: Morlaix
country: France
facility: Morlaix Hospital
city: Nantes
country: France
facility: CSAPA "Le triangle"
city: Nantes
country: France
facility: University Hospital Nantes
city: Saint Nazaire
country: France
facility: CSAPA-CAARUD "La rose des vents"
city: Saint-Sébastien-sur-Loire
country: France
facility: Réseau toxicomanie de la région nantaise
Study officials:
affiliation: Nantes University Hospital
name: Marie Grall-Bronnec, PH
role: STUDY_DIRECTOR
affiliation: Nantes University Hospital
name: Régis Bouquié, AHU
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Stéphane Bézieau, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Brest
name: Pierre Bodenez
role: PRINCIPAL_INVESTIGATOR
affiliation: Morlaix Hospital
name: Morgane Guillou-Landréat
role: PRINCIPAL_INVESTIGATOR
affiliation: Medico-psychological regional service nantes University Hospital
name: Bertrand Legeay
role: PRINCIPAL_INVESTIGATOR
affiliation: La Métairie center care support and prevention of addiction
name: Isabelle Martineau
role: PRINCIPAL_INVESTIGATOR
affiliation: La Rose des Vents center care support and prevention of addiction
name: Philippe Levassor
role: PRINCIPAL_INVESTIGATOR
affiliation: General practitioners in the drug-addiction network of the Nantes Area
name: Jean-Yves Guillet
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.