Opioid use disorder (OUD) is a chronic and severe psychiatric condition defined by a level of opioid use which significantly impairs interpersonal and social functioning. In the biopsychosocial model of addiction, research has shown that psychiatric, sociological and neurobiological factors individually affect OUD severity. However, how these factors interact in the determination of OUD severity remains poorly understood.

The Epigenetic Bonds of Opioid Use Profiles are a multidisciplinary project whose primary objective is to characterise psychiatric and social factors of OUD in a large cohort of patients. The secondary objectives are, first, to correlate psychosocial severity with blood-derived epigenetic biomarkers to provide a deeper understanding of determinants of OUD and, second, to examine over a 2 year follow-up the correlation between the evolution of OUD and psychosocial severity with epigenetic biomarkers at inclusion. An additional objective is to analyse the impact of drug consumption rooms on access to care for most severely affected patients with OUD. In total, 300 opioid users will be recruited at supervised injection sites in Strasbourg and Paris and at addiction care centres in Strasbourg and Lyon to explore four psychiatric (substance use disorders beyond opioids, depression, anxiety, post-traumatic stress disorder) and five social (social support and status, traumatic experiences, housing, imprisonment, access to care) factors. Opioid users will be followed for 24 months and reassessed for psychosocial factors at 3, 6, 12, 18 and 24 months. Opioid consumption will be measured in all subjects using questionnaires, complemented by toxicological screenings (mass spectrometry). Finally, DNA methylation and gene expression will be characterised in capillary blood using next-generation sequencing. Mixed models will be used to model the primary and secondary outcomes.

This ongoing study was approved by the French Ethics Committee ‘Sud Méditerranée III’ of University Hospital of Nîmes (approval 2023–2024, protocol IDRCB number 2022-A02477-36) and authorised by the French Data Protection Authority (authorisation decision DR-2023–277 in December 2023). Results will be presented in international and national conferences and published in peer-reviewed international journals.

NCT06021548.

Parents of children with neurodevelopmental disorders often experience high levels of stress that impact their mental health, yet few interventions focus on their well-being. To address this gap, we developed a mental health intervention based on emotional intelligence (EI), designed for delivery in healthcare settings. We hypothesise that enhancing EI can reduce parenting stress and improve psychological well-being. This study aims to assess the effectiveness, cost-effectiveness and feasibility of this EI-based intervention in Bangladesh.

This hybrid type 1 effectiveness-implementation study will include a cluster randomised controlled trial, an implementation analysis and an economic evaluation. Eight child development centres will be randomly assigned in a 1:1 ratio to intervention and waitlist control groups. A total of 480 parents (mothers and fathers) will be recruited. The intervention consists of interactive sessions on EI skills, supported by personal diaries and a mobile app. Data will be collected at baseline and 12 weeks postintervention using validated tools to assess EI, parenting stress, psychological well-being and other mental health outcomes. Implementation will be evaluated using mixed methods to assess feasibility, acceptability and fidelity. Cost-effectiveness will be determined through a cost–utility analysis of direct and indirect costs.

Ethical approval was granted by the Institutional Review Board of Bangladesh Medical University (BSMMU/2022/10733). Written informed consent will be obtained at each stage of data collection and intervention. Findings will be disseminated through open-access publications, plain-language summaries, academic conferences, community workshops and policy briefs. Data will be shared in open-access platforms to inform mental health strategies in low-resource settings globally.

NCT06166550.