Status:
RECRUITING
Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Brief Summary
Opioid use disorder (OUD) is a chronic and severe psychiatric condition, defined by problematic opioid use, that significantly impairs interpersonal and social functioning. Over the last 10 years, a d...
Detailed Description
First aim of the study is to systematically characterize OUD severity (DSM-5 criteria) and psychosocial factors in N=350 individuals with OUD, recruited at Safe Injection Sites (SIS), and other addict...
Eligibility Criteria
Inclusion
- 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), or a Center for Reception and Accompaniment in Harm Reduction for Drug Users (CAARUD)
- 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
- 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)
Key Trial Info
Start Date :
February 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 14 2029
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06021548
Start Date
February 7 2024
End Date
May 14 2029
Last Update
June 6 2024
Active Locations (3)
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1
Service Universitaire d'Addictologie, Hospices Civils de Lyon
Bron, France, 69678
2
Centre d'étude des mouvements sociaux (CEMS) UMR8044/INSERM U1276 - École des Hautes Etudes en Sciences Sociales (EHESS)
Paris, France, 75006
3
Service d'Addictologie, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091