BEBOP is a prospective, multicenter, national, comparative, non-randomized, open cohort study aiming to characterize opioid use disorder (OUD) severity and psychosocial severity among adults who use opioids, and to identify biological and psychosocial factors associated with OUD severity and its clinical evolution over a 2-year follow-up period.
BEBOP is a prospective, multicenter, national, comparative, non-randomized, open cohort study conducted among adults who use opioids and are recruited from Supervised Drug Consumption Facilities (SCMRs) and Addiction Care, Prevention and Support Centers (CSAPA) in Paris, Strasbourg and Lyon, France. The study aims to characterize different levels of OUD severity and psychosocial severity and to investigate their associations with biological markers measured in peripheral blood. OUD severity is assessed using DSM-5 diagnostic criteria. Psychosocial severity includes social, socioeconomic and psychiatric factors, including other substance use, depressive and anxiety symptoms, post-traumatic stress symptoms, sleep disorders and psychotic disorders. The study also aims to identify transcriptional and DNA methylation profiles associated with OUD severity and psychosocial severity, and to investigate whether biological and psychosocial characteristics assessed at inclusion are associated with the clinical evolution of OUD and psychosocial severity over a 2-year follow-up period. Participants are followed from baseline (M0) through visits at M3, M6, M12, M18 and M24. Biological samples include saliva and, when feasible, hair collected at baseline, and capillary blood samples collected at baseline and at M12
Study Type
OBSERVATIONAL
Enrollment
300
Finger stick blood spots will be collected at V0 and M12
Saliva sample will be collected at V0
Hair sample will be collected at V0 (optional)
Service Universitaire d'Addictologie, Hospices Civils de Lyon
Bron, France
RECRUITINGCentre d'étude des mouvements sociaux (CEMS) UMR8044/INSERM U1276 - École des Hautes Etudes en Sciences Sociales (EHESS)
Paris, France
RECRUITINGService d'Addictologie, Hôpitaux Universitaires de Strasbourg
Strasbourg, France
To systematically characterize OUD severity (DSM -5 criteria ) and psychosocial factors in N=300 individuals with OUD
Assessment of opioid use disorder (OUD) severity using DSM-5 diagnostic criteria and assessment of psychosocial severity based on sociodemographic, socioeconomic, social and psychiatric characteristics at baseline. OUD severity will be categorized according to the number of DSM-5 criteria: presence of OUD (≥2 criteria) versus absence of OUD (\<2 criteria), and severe OUD (≥6 criteria) versus non-severe OUD (\>2 and \<6 criteria). Associations between OUD severity categories and psychosocial severity parameters will be assessed using bivariate and multivariable analyses.
Time frame: At inclusion
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
Time frame: At inclusion and 24 month after inclusion
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