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Substance Use DisorderOPALNCT01847729

OPAL: "Opiates and PhArmacoLogy"

An observational study of Substance Use Disorder, run by Nantes University Hospital at 7 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Substance Use Disorder
How many people
263 participants
Where
7 sitesFrance
Study dates
11 Jul 2013to 21 Jul 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • Brest Universit Hospital

    Brest, 29820

  • CSAPA "La métairie"

    La Roche-sur-Yon, 85000

  • Morlaix Hospital

    Morlaix, 29672

  • CSAPA "Le triangle"

    Nantes, 44000

  • University Hospital Nantes

    Nantes, 44093

  • CSAPA-CAARUD "La rose des vents"

    Saint-Nazaire, 44600

  • Réseau toxicomanie de la région nantaise

    Saint-Sébastien-sur-Loire, 44230

Other trials in France

About this study

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.

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.

Read the 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.

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
Medical subject headings
Substance-Related Disorders, Opioid-Related Disorders, Gambling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01847729
Study groupRoleWhat they receive
Patients on OST prescribed to treat opiate dependenceCollecting socio-demographic data, data concerning opiate dependence, data about other substance use disorder, data regarding gambling practice, psychopathological data.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence or absence of co-addictions (exept tobacco dependence)

    Questionnaire

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2013 (estimated)
  2. Study start11 Jul 2013
  3. Primary completion21 Jul 2016
  4. Study completion21 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01847729
Sponsor's protocol ID
RC12_0498
Acronym
OPAL
Status last verified
Dec 2018
First submitted
10 Apr 2013
Last updated
12 Dec 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23334576

  • 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.

    PubMed 21698341

  • 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.

    PubMed 21654176

  • 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.

    PubMed 39252018

  • 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.

    PubMed 35346219

  • 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.

    PubMed 33546494

Questions about this trial

What is this clinical trial studying?

An observational study of Substance Use Disorder, run by Nantes University Hospital at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence or absence of co-addictions (exept tobacco dependence) (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01847729, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.

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