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

NCT03729388 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2022-09-01

No results posted yet for this study

Summary

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.

Conditions

  • Opioid-use Disorder

Interventions

OTHER

Prognosis factor associated with good outcome.

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.

Sponsors & Collaborators

  • CSAPA Apsyades

    collaborator UNKNOWN

  • OPPELIA-Le triangle

    collaborator UNKNOWN

  • Nantes University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-28
Primary Completion
2022-05-28
Completion
2022-05-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03729388 on ClinicalTrials.gov