Understanding addiction in opioid users through a comprehensive approach

Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach

This study looks at how serious opioid addiction is and what factors affect it in people using safe injection sites in France, while also checking their blood for clues that might help understand and predict their addiction over two years.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Strasbourg, France (Academic / other)
• Locations: 3 sites (Bron and 2 other locations)
• Trial ID: NCT06021548 on ClinicalTrials.gov

What this trial studies

This observational study aims to characterize the severity of opioid use disorder (OUD) and associated psychosocial factors in 350 individuals recruited from safe injection sites and addiction-related facilities in France. It will examine genome-wide epigenetic regulation and gene expression in blood samples to explore the relationship between molecular measures and OUD severity. Additionally, the study will track the evolution of OUD and psychosocial factors over two years to identify predictive molecular biomarkers. This integrated approach combines insights from psychiatry, sociology, and neurobiology to better understand addiction.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 18 and older who are French-speaking and currently using illegal opioids or prescribed opioid medications.

Not a fit: Patients who do not use opioids or are not currently engaged in addiction treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for individuals suffering from opioid use disorder.

How similar studies have performed: While the biopsychosocial model has been widely discussed, this specific integrated approach combining epigenetics and psychosocial factors in OUD is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Male, female, or transgender person, age \> 18 years
* French speaking subject, able to understand the objectives and risks of the research
* Informed signed consent form by the curator (subject under curatorship) / guardian (subject under guardianship), if applicable
* Subject who has written "I consent" on the consent form
* Subject using psychoactive substances and who attends a low-risk consumption room (SCMR), or a Center for Care, Accompaniment and Prevention in Addictology (CSAPA), or a Center for Reception and Accompaniment in Harm Reduction for Drug Users (CAARUD)
* Subject who used one or more illegal opioid drugs or one or more medications (with or without a prescription) at least once in the last 3 months (heroin, buprenorphine, morphine sulfate, methadone, morphine derivatives, oxycontin, oxycodone, oxynorm, Subutex® (Sub), Temgesic®, Suboxone®, Orobupre®, Skenan®, Moscontin®, opium, pethidine, codeine, dinacode, neocodion, codeine efferalgan, Lamaline®, tramadol, durogesic patches, fentanyl...)

Exclusion Criteria:

* Inability to give the subject informed information (subject with difficulties in understanding)
* Subject in an emergency or life-threatening situation
* Subject under court protection (upon subject's declaration)
* Subject participating in an investigational drug study (upon subject's declaration)

Where this trial is running

Bron and 2 other locations

• Service Universitaire d'Addictologie, Hospices Civils de Lyon — Bron, France (Recruiting)
• Centre d'étude des mouvements sociaux (CEMS) UMR8044/INSERM U1276 - École des Hautes Etudes en Sciences Sociales (EHESS) — Paris, France (Recruiting)
• Service d'Addictologie, Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)

Study contacts

• Study coordinator: Laurence LALANNE, MD

Conditions Opioid Use Disorder; Psychiatry, Neurobiology, Epidemiology, Bioinformatics