Biopsychosocial Markers of Addiction in Opioid Users: an Integrated Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- To systematically characterize OUD severity (DSM -5 criteria ) and psychosocial factors in N=300 individuals with OUD
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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...)
排除标准
- •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)
结局指标
主要结局
To systematically characterize OUD severity (DSM -5 criteria ) and psychosocial factors in N=300 individuals with OUD
时间窗: 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.
次要结局
- 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.(At inclusion and 24 month after inclusion)