OPAL: "Opiates and PhArmacoLogy"

Substance Use Disorder Clinical Trial

— OPAL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847729
• Other study ID #: RC12_0498
• Status: Completed
• Start date: July 11, 2013
• Est. completion date: July 21, 2016

Study information

• Verified date: December 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: July 21, 2016
• Est. primary completion date: July 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Substance Use Disorder
• Substance-Related Disorders

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

Grall-Bronnec M, Wainstein L, Augy J, Bouju G, Feuillet F, Vénisse JL, Sébille-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. — View Citation

Grall-Bronnec M, Wainstein L, Feuillet F, Bouju G, Rocher B, Vénisse JL, Sébille-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of co-addictions (exept tobacco dependence)	Questionnaire	1 day