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Completed

NCT Number: NCT03729388

Treatment for Opiate Addiction: Prognostic fActors of Responsiveness to Maintenance Treatment

A global and integrative treatment of opioid-use disorders (OUD) with opiate maintenance therapy (OMT) and psychosocial interventions is recommended by all current guidelines. Treatment of OUD aim at prevents risks and consequences of opioid use (death by overdose, contamination with infectious diseases, mental and physical degradation, social exclusion and decrease of quality of life). OMT are approved since more than 20 years for OUD and a large number of patients have been treated. Nevertheless, identification of prognosis factors associated with good outcome is still limited. OMT duration, high dosages of OMT and patient good consistency have been identified as good prognosis factors but other individual factors could be involved and explain why OMT isn't as effective for all patients. The investigators assume that social environment, other addictive behaviors, psychiatric comorbidities, personality disorders and pharmacogenetics parameters might be of interest. Association between phenotype/ genotype, safety of OMT and therapeutic outcome will be especially assessed. For voluntary patients specific tools for risk reduction will be implemented (screening of infectious diseases with blood tests and fibrosis with fibroscan). Thus, the aim of TOPAZE study is to highlight prognosis factors for good outcome in the treatment of OUD moderate to severe at 12 months follow-up. Three main axes will be considered: clinical, pharmacological and pharmacogenetics.

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Key information

Conditions

Opioid-use Disorder Behavior Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grall Bronnec, Nantes, France

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About this study

All patients with moderate or severe OUD diagnosis (according to Diagnostic and Statistical Manual Diploma in Social Medicine 5) who initiate OMT in addictionology department of Nantes hospital or in addiction care and prevention centers of Nantes could be included. Data will be collected during 3 visits.

During the first visit (inclusion), clinical interview, electrocardiogram, urinary and blood tests (pharmacokinetics and pharmacogenetics analysis) will be provided. Infectious disease screening and fibroscan could be also provided as the patient wishes. Inclusion visit will also correspond to initiation of OMT.

At 6 months follow-up (second visit) clinical interview, electrocardiogram, urinary and blood tests (pharmacokinetics and pharmacogenetics analysis) will be provided.

At 12 months follow-up (final visit) clinical interview, electrocardiogram and urinary test will be provided.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Minimum age of 18 years
  • Initiation of treatment with OMT (methadone or buprenorphine) for an OUD moderate to severe (according to DSM 5) in Nantes Hospital addictionology department or in an addiction care and prevention centers in Nantes.
  • Affiliated to social security
  • Consent to participate

Exclusion criteria

  • Upper cerebral function disorder inconsistent with participating in the study
  • Difficulty to understand, read or write French language
  • Adult under guardianship or curatorr
  • Pregnant woman

Treatment and study plan

Prognosis factor associated with good outcome.

Other

Implementation of a systematic assessment of patient with OMT initiation. Patients included in the TOPAZE study will receive standardized clinical interviews, electrocardiograms, urinary and blood tests during a 12 months follow-up.

Primary outcomes

  1. Clinical, pharmacokinetics and pharmacogenetics characteristics associated with good outcome of patients treated with OMT.

    Time frame: 12 months

    Good outcome is defined as early remission of opioid-related disorder according to Diagnostic and Statistical Manual of Mental Disorders Fifth version (none of the diagnostic criteria except craving within last three months) and no initiation or worsening of other addictive behavior (substance use disorders or gambling disorder according to Diagnostic and Statistical Manual of Mental Disorders Fifth version within last 12 months).

Secondary outcomes

  1. Prevalence of good outcome after an OMT treatment initiation.

    Time frame: 12 months

    Good outcome is defined as early remission of opioid-related disorder according to Diagnostic and Statistical Manual of Mental Disorders Fifth version (none of the diagnostic criteria except craving within last three months) and no initiation or worsening of other addictive behavior (substance use disorders or gambling according to Diagnostic and Statistical Manual of Mental Disorders Fifth version within last 12 months).

  2. Reasons for dropping-out of treatment.

    Time frame: 12 months

    Prevalence of each reason will be described (stopping treatment, death…).

  3. Clinical characteristics of patients: history of psychoactive substance consumptions, psychiatric comorbidities and addictive behaviors, risky behaviors (intravenous administration, sharing equipment and sexual behavior).

    Time frame: 12 months

  4. Number of participants with variation in the cytochrome P450 (CYP) enzyme with focus on CYP2B6, CYP2C19, CYP2D6, CYP3A4 polymorphisms using next-generation sequencing.

    Time frame: At inclusion

    Prevalence of CYP2B6, CYP2C19, CYP2D6 and CYP3A4 variants.

  5. Pharmacokinetics of OMT elimination.

    Time frame: 6 months

    Residual plasmatic concentration will be considered.

  6. Number of participants with methadone-associated Q-T interval prolongation as assessed by electrocardiogram [safety].

    Time frame: 12 months

    Prevalence of methadone-associated Q-T interval prolongation.

  7. Number of participants who accept to participate to a specific consultation with a hepatologist with a formation in risk reduction.

    Time frame: At inclusion

    Prevalence of participants who accept the hepatologist consultation and to be tested with blood tests for viral infections and fibroscan for hepatic fibrosis.

  8. Number of participants with variation of the Permeability-glycoProtein (P-gP) using next-generation sequencing.

    Time frame: At inclusion

    Prevalence of P-gP variants.

  9. Number of participants with variation in the OPRM1 gene (coding for µ receptor) using next-generation sequencing.

    Time frame: At inclusion

    Prevalence of OPRM1 variants.

  10. Number of participants with urine tests results in accordance with a good compliance [compliance].

    Time frame: At inclusion

    Prevalence of participants with positive urine tests results for OMT without any positive urine tests results for illicit substances or drugs without prescription.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • CSAPA Apsyades
  • OPPELIA-Le triangle

Registry information

Acronym: TOPAZE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 2, 2018
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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