Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach

NCT06021548 | Active Not Recruiting

• 1 other identifier: 8668
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 3

Brief 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. 1.Social and psychiatric factors together contribute to OUD severity;
2. 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. 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.

Conditions

Opioid Use Disorder

Keywords

Psychiatry, Neurobiology, Epidemiology, Bioinformatics

Outcome Measures

Primary Outcomes (1)

• To systematically characterize OUD severity (DSM -5 criteria ) and psychosocial factors in N=300 individuals with OUD

  Opioid users will be recruitedat Safe Injection Sites (SIS) where we are privileged access, and others addiction related facilities (French CSAPA,CAARUD, and pain treatment centers. Recruitment at SIS will allow the investigators to target OUD patients at highest psychosocial risk, who remained mostly out-of-reach of previous studies, and to compare them to stabilized OUD patients, overall covering a wide spectrum of desease course and severity.

  At inclusion

Secondary Outcomes (1)

• Examine genome -wide epigenic regulation and gene expression in peripheral blood samples collected from all subjects, at inclusion assess the evolution of OUD and psychosocial severity in the cohort, over 2 years.

  At inclusion and 24 month after inclusion

Interventions

Blood sample OTHER

Finger stick blood spots will be collected at V0 and M12

Saliva sample OTHER

Saliva sample will be collected at V0

Hair sample OTHER

Hair sample will be collected at V0 (optional)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited: * in the 2 SIS in Paris (Gaia) and Strasbourg (Ithaque), * in French addiction care centers: CSAPA (primary care outpatient settings for patients with addiction) in Strasbourg, Paris and Lyon

You may qualify if:

• 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...)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (3)

Service Universitaire d'Addictologie, Hospices Civils de Lyon

Bron, 69678, France

Location

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

Paris, 75006, France

Location

Service d'Addictologie, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

• Lalanne L, Lutz PE, Caparros-Roissard A, Ruppert E, Waeckerle G, Scherer C, Oster F, Brand C, Henck S, Soavelo H, Ramousset C, Lebreton M, Audran M, Lazic J, Detrez V, Avril E, Merah I, Chappuy M, Meyer N, Jauffret-Roustide M, Rolland B. Integrative exploration of bio-psycho-social determinants of DSM-5 severity levels of opioid use disorder: the BEBOP cohort study protocol. BMJ Open. 2025 Oct 13;15(10):e093358. doi: 10.1136/bmjopen-2024-093358.

  PMID: 41083308 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The samples will be taken by finger prick and blood collection (between 200 and 500 microliters per sample) on a capillary tube in order to avoid generating a craving by using phlebotomy to collect venous blood.

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 1, 2023
• Study Start: February 7, 2024
• Primary Completion (Estimated): May 14, 2029
• Study Completion (Estimated): May 14, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)