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ACTIVE NOT RECRUITING
NCT06021548

Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

Summary

Opioid use disorder (OUD) is a chronic and severe psychiatric condition, defined by problematic opioid use, that significantly impairs interpersonal and social functioning. Over the last 10 years, a dramatic increase in the prevalence of OUD and deaths by overdose has occurred in several developed countries, in particular the USA. In France, similarly, the burden associated with OUD is worsening, and now represents a major public health crisis. During last decades, it has been demonstrated that OUD results from combined effects of numerous factors, which have been robustly identified across a variety of research fields, including psychiatry, sociology, and neurobiology. This plurality is embodied in a comprehensive theoretical framework, the biopsychosocial model of addiction, composed of elements whose effects have been well defined individually, but remain poorly characterized and understood in combination. More recently, behavioral epigenetics has emerged as a promising discipline to identify molecular mechanisms that may help explain how life experiences, in particular psychiatric and sociological factors, modulate the regulation of genes, brain function, and emotional regulation. In this context, here we propose a multidisciplinary project that builds on the collaboration of psychiatrists, sociologists and neuro-epigeneticists. The investigators will simultaneously characterize major psychiatric and social factors in a large cohort of individuals with OUD, with the goal of covering the full spectrum of disease severity. By combining deep psychosocial evaluation with the investigation of blood-derived epigenetic biomarkers, they will seek to provide a new and deeper understanding of determinants of OUD severity. The project builds on 3 main hypotheses: 1. Social and psychiatric factors together contribute to OUD severity; 2. Epigenetic mechanisms, measured in peripheral accessible tissues such as blood, represent biomarkers that may reflect pathophysiological processes resulting, at least in part, from the effects of psychosocial factors; 3. Measures of OUD severity combining both psychosocial factors and epigenetic biomarkers have the potential to improve our ability to describe OUD severity, and better predict its clinical course.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

350

Start Date

2024-02-07

Completion Date

2029-05-14

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

OTHER

Blood sample

Finger stick blood spots will be collected at V0 and M12

OTHER

Saliva sample

Saliva sample will be collected at V0

OTHER

Hair sample

Hair sample will be collected at V0 (optional)

Locations (3)

Service Universitaire d'Addictologie, Hospices Civils de Lyon

Bron, France

Centre d'étude des mouvements sociaux (CEMS) UMR8044/INSERM U1276 - École des Hautes Etudes en Sciences Sociales (EHESS)

Paris, France

Service d'Addictologie, Hôpitaux Universitaires de Strasbourg

Strasbourg, France