Understanding addiction in opioid users through a comprehensive approach

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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)
* 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 it's running

• 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
• Email: laurence.lalanne@chru-strasbourg.fr
• Phone: 33.3.88.11.51.35

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.