Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach
ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Participants will be recruited from Supervised Drug Consumption Facilities (SCMRs) and Addiction Care, Prevention and Support Centers (CSAPAs) located in Paris, Strasbourg and Lyon, France.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood sample
Other interventionFinger stick blood spots will be collected at V0 and M12
Saliva sample
Other interventionSaliva sample will be collected at V0
Hair sample
Other interventionHair sample will be collected at V0 (optional)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 inclusionSecondary outcomes
1
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 inclusionSponsors and contacts
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Source ClinicalTrials.gov