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Insomnia is a common complaint among patients with opioid use disorder (OUD) maintained on buprenorphine (BUP). However, people with OUD have historically been excluded from insomnia clinical trials, leaving clinicians without evidence-based treatment options for this patient population. Lemborexant, the Food and Drug Administration (FDA)-approved dual orexin receptor antagonist for the treatment of insomnia, was recently shown to be safe and tolerable among a sample of patients with insomnia who were maintained on BUP. We hypothesise that pharmacologically antagonising the orexin system with lemborexant may improve insomnia symptoms in individuals with OUD and also enhance BUP treatment benefits by improving performance in neurofunctional domains identified in the National Institute on Drug Abuse Phenotyping Assessment Battery.
Participants with insomnia and OUD who have been stabilised on BUP for at least 4 weeks will be randomly assigned to receive either lemborexant (n=50) or placebo (n=50) for 8 weeks. Participants will complete assessments at baseline, during the 8-week intervention, postintervention and at a 2-week follow-up. Primary outcomes are insomnia severity and impulsivity. Secondary measures include objective sleep metrics (total sleep time, sleep efficiency, sleep onset latency and wake after sleep onset) and performance in the neurofunctional domains of negative emotionality and metacognition.
The study was approved by the Virginia Commonwealth University Institutional Review Board in April 2025 (protocol number HM20031777). Data collection began in May 2025 and is expected to be completed by May 2029. The trial is conducted under FDA IND no. 154797 (FGM). The dissemination plan for the trial includes presentations at local and national conferences, submission of primary and secondary outcome manuscripts for publication in peer-reviewed journals and circulation of findings to popular media outlets, as available. Results will also be shared with interested participants and clinical collaborators upon completion of the trial.
To achieve an in-depth understanding of the challenges associated with diabetes management when having both schizophrenia and type 2 diabetes, while also identifying the needs for improved diabetes self-care.
The study employed a qualitative explorative design utilizing a phenomenological-hermeneutic inspired approach, involving field observations and individual semistructured interviews.
Data were collected during 2020–2021 through 17 field observations of outpatient consultations and 13 individual semistructured interviews. Data, including field notes and verbatim transcribed interviews, underwent analysis following Ricoeur's interpretive philosophy, encompassing three levels: naïve reading, structural analysis and critical interpretation and discussion. This study adheres to the COREQ guidelines for qualitative research.
Three key themes emerged: ‘Diabetes when life is noisy’, ‘Sacrifices and compromises in life’ and ‘The double silence’. Everyday life is significantly affected when having both schizophrenia and T2D. The mental health state dominates in relation to diabetes self-care and individuals experience challenges balancing between the two conditions. However, there exists a general acknowledgement for diabetes and its long-term complications as a serious medical condition demanding careful attention and treatment.
Self-managing two such complex conditions can be overwhelming and make it difficult for the individual to differentiate symptoms and prioritize diabetes care. Moreover, the existing fragmentation within healthcare systems poses communication challenges, resulting in disjointed patient pathways.
The study emphasizes the need for a holistic re that addresses the physical, emotional and social challenges. There is also a need for increased awareness and education among informal caregivers and healthcare professionals to foster better understanding and support.
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