Opioid Use DisorderBEBOPNCT06021548
Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach
An observational study of Opioid Use Disorder, run by University Hospital, Strasbourg, France at 3 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Blood sample, Saliva sample and Hair sample
- How many people
- 300 participants
- Where
- 3 sitesFrance
- Study dates
- 27 Feb 2024to 14 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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...)
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Service Universitaire d'Addictologie, Hospices Civils de Lyon
Bron, 69678
Benjamin ROLLAND, MD, 33.4.37.91.55.55, benjamin.rolland@ch-le-vinatier.fr
Benjamin ROLLAND, MD
- Recruiting
Centre d'étude des mouvements sociaux (CEMS) UMR8044/INSERM U1276 - École des Hautes Etudes en Sciences Sociales (EHESS)
Paris, 75006
Marie JAUFFRET-ROUSTIDE, 33.6.10.55.32.87, marie.jauffret-roustide@inserm.fr
Marie JAUFFRET-ROUSTIDE
- Recruiting
Service d'Addictologie, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Laurence LALANNE, MD, 33.3.88.11.51.35, laurence.lalanne@chru-strasbourg.fr
Flavie OSTER, MD
About this study
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.
Read the 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
- Conditions
- Opioid Use Disorder
- Being tested
- Blood sample, Saliva sample, Hair sample
- Keywords
- Psychiatry, Neurobiology, Epidemiology, Bioinformatics
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Finger stick blood spots will be collected at V0 and M12
Saliva sampleOther
Saliva sample will be collected at V0
Hair sampleOther
Hair sample will be collected at V0 (optional)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion
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.
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
Measured: At inclusion and 24 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start27 Feb 2024
- Primary completion14 May 2029 (estimated)
- Study completion14 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021548
- Sponsor's protocol ID
- 8668
- Acronym
- BEBOP
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lalanne L, Lutz PE, Caparros-Roissard A, Ruppert E, Waeckerle G, Scherer C, Oster F, Brand C, Henck S, Soavelo H, Ramousset C, Lebreton M, Audran M, Lazic J, Detrez V, Avril E, Merah I, Chappuy M, Meyer N, Jauffret-Roustide M, Rolland B. Integrative exploration of bio-psycho-social determinants of DSM-5 severity levels of opioid use disorder: the BEBOP cohort study protocol. BMJ Open. 2025 Oct 13;15(10):e093358. doi: 10.1136/bmjopen-2024-093358.
PubMed 41083308
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach
- ClinicalTrials.gov ID
- NCT06021548
- Acronym / sponsor ID
- BEBOP / 8668
- Conditions
- Opioid Use Disorder
- Keywords
- Psychiatry, Neurobiology, Epidemiology, Bioinformatics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 14 May 2029 (estimated)
- Study completion
- 14 May 2029 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleFinger stick blood spots will be collected at V0 and M12 | Other | – |
| Saliva sampleSaliva sample will be collected at V0 | Other | – |
| Hair sampleHair sample will be collected at V0 (optional) | Other | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Derived from this study: PubMed 41083308Lalanne L, Lutz PE, Caparros-Roissard A, Ruppert E, Waeckerle G, Scherer C, Oster F, Brand C, Henck S, Soavelo H, Ramousset C, Lebreton M, Audran M, Lazic J, Detrez V, Avril E, Merah I, Chappuy M, Meyer N, Jauffret-Roustide M, Rolland B. Integrative exploration of bio-psycho-social determinants of DSM-5 severity levels of opioid use disorder: the BEBOP cohort study protocol. BMJ Open. 2025 Oct 13;15(10):e093358. doi: 10.1136/bmjopen-2024-093358.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder, run by University Hospital, Strasbourg, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence LALANNE, MD (33.3.88.11.51.35, laurence.lalanne@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To systematically characterize OUD severity (DSM -5 criteria ) and psychosocial factors in N=300 individuals with OUD (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06021548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.