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

NCT ID: NCT03729388

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-28
• Study Completion Date: 2022-05-28

Brief 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.

Detailed Description

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.

Conditions

Opioid-use Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSAPA Apsyades

UNKNOWN

Sponsor Role: collaborator

OPPELIA-Le triangle

UNKNOWN

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Grall Bronnec

Nantes, , France

OPPELIA-Le triangle

Nantes, , France

Countries

France

Other Identifiers

RC17_0377

Identifier Type: -

Identifier Source: org_study_id