The J Healthcare Initiative is seeking to design a clinical trial for an inhalable fentanyl derivative aimed at treating patients with treatment-refractory opioid use disorder (OUD). The goal is to reduce illicit fentanyl use among this patient population that did not benefit from buprenorphine and methadone treatment, failed diamorphine treatment, by providing a safer, controlled alternative to unregulated fentanyl. The project will involve a comprehensive review of existing literature on diamorphine clinical trials, identification of key metrics for success, and the creation of a detailed trial protocol. This includes defining patient selection criteria, dosage, administration methods, and safety monitoring procedures. The project will provide learners with an opportunity to apply their knowledge of clinical research methodologies, pharmacology, and ethical considerations in medical trials.

- A comprehensive literature review on clinical trials for inhalable medications and fentanyl derivatives.

- A detailed clinical trial protocol document, including patient selection criteria, dosage, administration methods, and safety monitoring procedures.

- A presentation summarizing the trial design, objectives, and expected outcomes.

- A risk assessment report identifying potential challenges and ethical considerations in the trial.