The FDA is considering approving the first psychedelic drug, MDMA-assisted therapy for PTSD. However, a major issue in clinical trials with psychedelics is that participants often know whether they received the drug or a placebo, impacting the results. Some experts believe this could undermine psychedelic research. Others think the problem lies with the traditional randomized controlled trial (RCT) model. RCTs may not be the best method for studying psychedelics due to the inability to blind participants effectively. Alternative study designs, like open-label trials and descriptive studies, may provide a more comprehensive understanding of how psychedelics work and could be more beneficial for mental health interventions.
https://www.theatlantic.com/health/archive/2024/06/psychedelics-mdma-ptsd-fda-placebo/678588/