blood sample
OtherFinger stick blood spots will be collected at V0 and M12
NCT Number: NCT06021548
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Service Universitaire d'Addictologie, Hospices Civils de Lyon, Bron, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
Laurence LALANNE, MD
CONTACT
Pierre Eric LUTZ
CONTACT
University Hospital, Strasbourg, France
Other
Acronym: BEBOP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05995886
Chemically-Induced Disorders, Mental Disorders
Rochester, Minnesota, United States
View Trial DetailsNCT07420283
Chemically-Induced Disorders, Mental Disorders
Phoenix, Arizona, United States
View Trial DetailsNCT05683184
Chemically-Induced Disorders, Healthy Control
New Haven, Connecticut, United States
View Trial DetailsNCT06943859
Behavior, Chemically-Induced Disorders
Baltimore, Maryland, United States
View Trial Details