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NCT Number: NCT06021548

Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service Universitaire d'Addictologie, Hospices Civils de Lyon, Bron, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

blood sample

Other

Finger stick blood spots will be collected at V0 and M12

Saliva Sample

Other

Saliva sample will be collected at V0

Hair sample

Other

Hair sample will be collected at V0 (optional)

Primary outcomes

  1. To systematically characterize OUD severity (DSM -5 criteria ) and psychosocial factors in N=300 individuals with OUD

    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.

Secondary 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.

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Laurence LALANNE, MD

CONTACT

[email protected]

33.3.88.11.51.35

Pierre Eric LUTZ

CONTACT

[email protected]

33.3.88.45.67.29

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: BEBOP

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Sep 1, 2023
Registry last updated
Aug 25, 2026

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.

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