Overview
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.
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
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)
- 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)
