Disease: posttraumatic stress disorder (PTSD)

From Efficacy to Effectiveness: Evaluating Psychedelic Randomized Controlled Trials for Trustworthy Evidence-Based Policy and Practice

This paper discusses why testing psychedelic therapies in clinical trials is more complicated than testing regular drugs. When people take psychedelics like MDMA or psilocybin, they clearly notice the effects, which makes it hard to keep the study ‘blinded’ (where neither patients nor researchers know who got the real drug). The author argues that for therapies combining drugs with counseling, this actually makes sense because the therapy itself is part of how the treatment works, not just a confounding factor. However, for stand-alone drug use, this unblinding is a real problem that makes it unclear whether the drug or people’s expectations caused the improvement.

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Group psychedelic therapy: empirical estimates of cost-savings and improved access

This study examines whether treating multiple patients together in psychedelic-assisted therapy sessions could reduce costs and help more people access these promising psychiatric treatments. Researchers compared group versus individual therapy using MDMA for PTSD and psilocybin for depression, finding that group therapy saved about 35-51% on clinician costs. If adopted widely, group therapy could reduce the number of clinicians needed and potentially save billions of dollars while helping thousands more patients receive treatment.

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A Review of the Food and Drug Administration Pipeline and Proposed California Legislation on Medicinal Psychedelics

Psychedelic compounds like psilocybin and ketamine show promise in treating serious mental health conditions including PTSD and depression. The FDA carefully evaluates these drugs through multi-phase clinical trials to ensure they are safe and effective. While California has proposed making psychedelics more widely available through legislation, the FDA’s thorough approval process provides important protections by identifying potential risks and ensuring proper medical oversight.

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Psilocybin-assisted massed cognitive processing therapy for chronic posttraumatic stress disorder: Protocol for an open-label pilot feasibility trial

This study tests whether psilocybin (a psychedelic compound) combined with intensive therapy can help treat chronic PTSD better than therapy alone. Fifteen patients with PTSD will receive one dose of psilocybin alongside 12 therapy sessions completed over a single week. Researchers will track feasibility, safety, symptom improvements, and use wearable devices to monitor physiological changes. The results will help determine whether larger trials should test this innovative combination therapy.

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