Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach

Opioid Use Disorder Clinical Trial

— BEBOP  

Official title:

Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021548
• Other study ID #: 8668
• Status: Recruiting
• Start date: February 7, 2024
• Est. completion date: May 14, 2029

Study information

• Verified date: June 2024
• Source: University Hospital, Strasbourg, France
• Contact: Laurence LALANNE, MD
• Phone: 33.3.88.11.51.35
• Email: laurence.lalanne[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

First aim of the study is to systematically characterize OUD severity (DSM-5 criteria) and psychosocial factors in N=350 individuals with OUD, recruited at Safe Injection Sites (SIS), and other addiction-related facilities: French low-risk consumption room (CSAPA), Center for Reception and Accompaniment in Harm Reduction for Drug Users (CAARUD), and pain treatment centers.

Recruitment at SIS will allow 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 disease course and severity.

Second aim of the study is to examine genome-wide epigenetic regulation (DNA methylation) and gene expression in peripheral blood samples collected from all subjects, at inclusion; then, to leverage systems biology to characterize relationships among these molecular measures and OUD and psychosocial severity;

Third aim of the study is to assess the evolution of OUD and psychosocial severity in the whole cohort, over 2 years, in order to determine how such evolution can be predicted using molecular epigenetic biomarkers defined at inclusion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: May 14, 2029
• Est. primary completion date: May 14, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Other:
• Blood sample
Finger stick blood spots will be collected at V0 and M12
• Saliva sample
Saliva sample will be collected at V0
• Hair sample
Hair sample will be collected at V0 (optional)

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Two secondary outcome will be measured (1) The investigators want to examine genome -wide epigenic regulation (DNA methylation) and gene expression in peripheral blood samples collected from all subjects, at inclusion; then to leverage systems biology to characterize relationships among these molecular measures and OUD and psychosocial severity (2) The investigators want to assess the evolution of OUD and psychosocial severirity in the whole cohort, over 2 years, in order to determine how such evolution can be predicted using molecular epigenic biomarkers defined at inclusion	At inclusion and 24 month after inclusion