Clinical Trials in France / NCT06021548
Recruiting
Observational
Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach
NCT06021548 · tracked via the Priya Life Science France tracker
Condition(s) studied
Opioid Use Disorder
Investigational drug(s) / intervention(s)
Blood sampleSaliva sampleHair sample
Blood sample: Finger stick blood spots will be collected at V0 and M12
Saliva sample: Saliva sample will be collected at V0
Hair sample: Hair sample will be collected at V0 (optional)
Study 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 over a 2-year follow-up period.
Eligibility
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)
Primary outcome measure(s)
- To systematically characterize OUD severity (DSM -5 criteria ) and psychosocial factors in N=300 individuals with OUD — 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.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Service Universitaire d'Addictologie, Hospices Civils de Lyon | Bron | France | Recruiting |
| Centre d'étude des mouvements sociaux (CEMS) UMR8044/INSERM U1276 - École des Hautes Etudes en Sciences Sociales (EHESS) | Paris | France | Recruiting |
| Service d'Addictologie, Hôpitaux Universitaires de Strasbourg | Strasbourg | France | Recruiting |
More University Hospital, Strasbourg, France trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06021548 on ClinicalTrials.gov ↗ ← All trials in France