Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach (BEBOP)

August 21, 2026 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69678
        • Recruiting
        • Service Universitaire d'Addictologie, Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Benjamin ROLLAND, MD
        • Sub-Investigator:
          • Mathieu CHAPPUY, MD
        • Sub-Investigator:
          • Ismahane MERAH, MD
      • Paris, France, 75006
        • Recruiting
        • Centre d'étude des mouvements sociaux (CEMS) UMR8044/INSERM U1276 - École des Hautes Etudes en Sciences Sociales (EHESS)
        • Contact:
        • Principal Investigator:
          • Marie JAUFFRET-ROUSTIDE
        • Sub-Investigator:
          • Mireille LEBRETON
        • Sub-Investigator:
          • Martin AUDRAN
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'Addictologie, Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Sub-Investigator:
          • Flavie OSTER, MD
        • Sub-Investigator:
          • Camille BRAND, MD
        • Sub-Investigator:
          • Sophie HENCK, MD
        • Principal Investigator:
          • Laurence LALANNE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At inclusion and 24 month after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2024

Primary Completion (Estimated)

May 14, 2029

Study Completion (Estimated)

May 14, 2029

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8668

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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