Psilocybin

FDA advisory panel rejected MDMA-assisted therapy for PTSD due to concerns over clinical trial design, potential abuse, and misconduct allegations. April Pride, CEO of SetSet, views this as a setback for psychedelic medicine, advocating for regulatory reforms and harm-reduction education. Despite the rejection, Pride remains optimistic about the future of psychedelic medicine, expecting innovation in safer compounds and protocols.

Classic psychedelics like LSD and psilocybin are well-tolerated in clinical settings, with serious adverse events being rare, according to a study in JAMA Psychiatry. However, incomplete adverse event reporting highlights the need for improved safety monitoring. The study found no serious adverse events among healthy participants, but about 4% of those with neuropsychiatric disorders experienced serious events. The research emphasizes the need for rigorous pharmacovigilance practices to accurately quantify risks and benefits.

Psyence Biomed to acquire Clairvoyant Therapeutics, which is conducting a Phase IIb clinical trial for a synthetic psilocybin candidate for Alcohol Use Disorder (AUD). Topline data expected in early 2025.

Mindstate Design Labs received FDA and EMA approval for human trials of MSD-001, described as 'psychedelic tofu' for its mild effects. The trials aim to validate the neurotech AI platform, Osmanthus, designed to create tailored altered states of consciousness. CEO Dillan DiNardo envisions using psychedelics as tools to understand and design specific mental states, potentially addressing conditions beyond traditional psychedelic uses.

Interventions for treatment-resistant depression (TRD) include augmentation and switch pharmacotherapy, psychotherapy, electroconvulsive therapy (ECT), and repetitive transcranial magnetic stimulation (rTMS). The STAR*D study guided TRD treatment for 20 years, showing difficulty in achieving remission. Since then, new treatments like atypical antipsychotic augmentation, intranasal esketamine, and rTMS have emerged, with rTMS being a significant advancement due to its efficacy and neuroscience-based tools for optimization. Recent studies like Dalhuisen et al. and ASCERTAIN-TRD suggest rTMS is more effective than pharmacotherapy in TRD, potentially positioning it earlier in treatment algorithms.

On Aug. 29, 2024, at 6 p.m., 'Health Matters' discusses methamphetamine addiction with Dr. Shawn McNeil, Kevin Murnane, PhD, and Frances Vest, focusing on a psilocybin clinical trial at LSU Health Shreveport. Call 1-800-552-8502 for questions.

Optimi Health Corp. received Health Canada's approval for a Phase 2 clinical trial using their GMP natural psilocybin extract capsules to study Major Depressive Disorder in 200 participants, focusing on frontline mental healthcare workers affected by COVID-19. The trial aims to assess the safety, efficacy, and therapeutic potential of psilocybin, potentially integrating it into clinical practice in Canada.

Thomas Hartle, the first Canadian to legally use psilocybin for end-of-life distress, died at 56. Diagnosed with stage 4 colon cancer, he found psychedelic-assisted therapy profoundly comforting, altering his perception of death. Despite psilocybin's illegality in Canada, Hartle advocated for its therapeutic potential beyond terminal illnesses, highlighting its impact on anxiety and depression.

Interest in psychedelics for mental health treatments surged, but faced a setback when FDA rejected MDMA for PTSD, citing need for more safety and efficacy research. This decision may push the research community back underground. The episode explores psychedelics' potential and challenges, including MDMA, ketamine for depression, and psilocybin for cluster headaches.