Opioid Use Disorder
Conditions
Keywords
Psychiatry, Neurobiology, Epidemiology, Bioinformatics
Brief summary
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.
Detailed description
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
Interventions
OTHERBlood sample
Finger stick blood spots will be collected at V0 and M12
OTHERSaliva sample
Saliva sample will be collected at V0
OTHERHair sample
Hair sample will be collected at V0 (optional)
Sponsors
University Hospital, Strasbourg, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To systematically characterize OUD severity (DSM -5 criteria ) and psychosocial factors in N=300 individuals with OUD | At inclusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
France
Contacts
CONTACTLaurence LALANNE, MD
CONTACTPierre Eric LUTZ
Outcome results
None listed