{"rows":[{"id":5676,"title":"Psilocybin therapy for adult females with anorexia nervosa: pilot study.","normalized_title":"psilocybin therapy for adult females with anorexia nervosa pilot study","authors":"Douglass HM, Spriggs MJ, Godfrey K, Danby JL, de Magalhaes FJC, Macdonald L, Alderton KL, Archer S, Ahmad K, Martell J, Frias JT, Sawicka G, Read T, Blemings A, Lafrance A, Nicholls D, Erritzoe D, Park RJ, Nutt DJ, Carhart-Harris RL.","abstract":"BackgroundAnorexia nervosa is a debilitating eating disorder with high mortality and chronicity rates owing to the paucity of effective existing treatments. Several clinical trials using psilocybin therapy have demonstrated therapeutic efficacy and safety in psychiatric conditions, including anorexia nervosa.AimsThis study aimed to further assess the safety, feasibility and potential efficacy of psilocybin therapy in anorexia nervosa.MethodThis single-blind, within-individual pilot study recruited 21 females with anorexia nervosa, who underwent three dosing sessions with oral psilocybin (COMP360) over 6 weeks in a fixed order (1 mg, 25 mg, 25 mg), alongside talk therapy and adjunctive to treatment as usual. Adverse events were monitored throughout the study. Primary clinical outcome measures were global Eating Disorder Examination Interview (EDE) and Readiness and Motivation Questionnaire (RMQ) precontemplation scores. Primary time points for the EDE were the 6-week final visit, 3-month follow-up and 6-month follow-up; and for the RMQ, they were the 6-week final visit and comparison between dosing days. Global EDE Questionnaire scores were a key secondary outcome. Key time points were the 6-week final visit and comparison between dosing days. There was a 12-month remote follow-up.ResultsPsilocybin was well tolerated by all participants. The most common adverse events were headache, nausea and dizziness. Two serious adverse events (suicide attempts) were reported for one participant within the 6-12-month period. Relative to baseline, participants displayed significant improvements in their eating disorder symptoms (EDE scores: p < 0.0001, d = 0.98, 6 months) and motivation to change (RMQ scores: p = 0.0017, d = 0.65, 12 months). However, there was a large variation in improvement and maintenance during the follow-up.ConclusionsThis study further provides preliminary support for the feasibility, safety and potential efficacy of this intervention to treat adult females with anorexia nervosa, and warrants further investigation in larger and more rigorously designed studies.","journal":"The British Journal of Psychiatry","publication_date":"2026-07-07","publication_year":2026,"doi":"10.1192/bjp.2026.10687","pubmed_id":"42414058","source_url":"https://doi.org/10.1192/bjp.2026.10687","keywords":"","substance_tags":"psilocybin","source_name":"Europe PMC","date_added":"2026-07-08 01:20:22","last_checked":"2026-07-09 01:20:15","raw_json":"{\"europe_pmc_id\":\"42414058\",\"source\":\"MED\",\"pub_type\":null,\"publisher\":null,\"importer\":\"Europe PMC\",\"openalex_enrichment\":{\"openalex_id\":\"https://openalex.org/W7167587921\",\"openalex_url\":\"https://openalex.org/W7167587921\",\"openalex_relevance_score\":11,\"openalex_relevance_reasons\":[\"title:psilocybin\",\"abstract:psilocybin\",\"metadata:psilocybin\",\"compound:comp360\"],\"openalex_type\":\"article\",\"openalex_work_type\":null,\"cited_by_count\":0,\"referenced_works\":[\"https://openalex.org/W1539080424\",\"https://openalex.org/W1554763052\",\"https://openalex.org/W1994387760\",\"https://openalex.org/W2001008250\",\"https://openalex.org/W2001060580\",\"https://openalex.org/W2055312975\",\"https://openalex.org/W2070836248\",\"https://openalex.org/W2093980670\",\"https://openalex.org/W2108143240\",\"https://openalex.org/W2564469912\",\"https://openalex.org/W2619816586\",\"https://openalex.org/W2753989225\",\"https://openalex.org/W2777124046\",\"https://openalex.org/W2883430979\",\"https://openalex.org/W2901877120\",\"https://openalex.org/W2998935314\",\"https://openalex.org/W3046100757\",\"https://openalex.org/W3080226154\",\"https://openalex.org/W3083797211\",\"https://openalex.org/W3087074748\",\"https://openalex.org/W3153606049\",\"https://openalex.org/W3164618783\",\"https://openalex.org/W3205506305\",\"https://openalex.org/W4221114092\",\"https://openalex.org/W4361279088\",\"https://openalex.org/W4379967727\",\"https://openalex.org/W4385197359\",\"https://openalex.org/W4387026668\",\"https://openalex.org/W4387674199\",\"https://openalex.org/W4394693583\",\"https://openalex.org/W4395110324\"],\"authorships\":[{\"id\":\"https://openalex.org/A5031966441\",\"display_name\":\"Hannah Douglass\",\"orcid\":\"https://orcid.org/0000-0002-4033-385X\"},{\"id\":\"https://openalex.org/A5140199765\",\"display_name\":\"Meg J. Spriggs\",\"orcid\":null},{\"id\":\"https://openalex.org/A5121806282\",\"display_name\":\"K. Godfrey\",\"orcid\":null},{\"id\":\"https://openalex.org/A5046578118\",\"display_name\":\"Jennifer L. Danby\",\"orcid\":null},{\"id\":\"https://openalex.org/A5140220796\",\"display_name\":\"Frederico J. C. de Magalhaes\",\"orcid\":null},{\"id\":\"https://openalex.org/A5109728412\",\"display_name\":\"Lauren Macdonald\",\"orcid\":null},{\"id\":\"https://openalex.org/A5008058826\",\"display_name\":\"Kirsty L. Alderton\",\"orcid\":null},{\"id\":\"https://openalex.org/A5140174385\",\"display_name\":\"Stephanie Archer\",\"orcid\":null},{\"id\":\"https://openalex.org/A5100595075\",\"display_name\":\"Kirran Ahmad\",\"orcid\":null},{\"id\":\"https://openalex.org/A5036560266\",\"display_name\":\"Jonny Martell\",\"orcid\":\"https://orcid.org/0000-0002-4194-7669\"},{\"id\":\"https://openalex.org/A5140192900\",\"display_name\":\"Jennifer T. Frias\",\"orcid\":null},{\"id\":\"https://openalex.org/A5115003013\",\"display_name\":\"Gabriela Sawicka\",\"orcid\":null},{\"id\":\"https://openalex.org/A5104065435\",\"display_name\":\"Tim Read\",\"orcid\":null},{\"id\":\"https://openalex.org/A5048534479\",\"display_name\":\"Allan Blemings\",\"orcid\":null},{\"id\":\"https://openalex.org/A5035542356\",\"display_name\":\"Adèle Lafrance\",\"orcid\":\"https://orcid.org/0000-0002-4935-7786\"},{\"id\":\"https://openalex.org/A5030053635\",\"display_name\":\"Dasha Nicholls\",\"orcid\":\"https://orcid.org/0000-0001-7257-6605\"},{\"id\":\"https://openalex.org/A5044907549\",\"display_name\":\"David Erritzøe\",\"orcid\":\"https://orcid.org/0000-0002-7022-6211\"},{\"id\":\"https://openalex.org/A5005010143\",\"display_name\":\"Rebecca J. Park\",\"orcid\":\"https://orcid.org/0000-0002-8611-4409\"},{\"id\":\"https://openalex.org/A5016082897\",\"display_name\":\"David Nutt\",\"orcid\":\"https://orcid.org/0000-0002-1286-1401\"},{\"id\":\"https://openalex.org/A5140218191\",\"display_name\":\"Robin L. Carhart-Harris\",\"orcid\":null}],\"primary_location\":{\"source_id\":\"https://openalex.org/S127936299\",\"source_display_name\":\"The British Journal of Psychiatry\",\"landing_page_url\":\"https://doi.org/10.1192/bjp.2026.10687\",\"is_oa\":false}}}","topic_tags":"Eating Disorders,Headache / Migraine,Clinical Trial,Safety,Adverse Events","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":"https://openalex.org/W7167587921"},{"id":3652,"title":"Phase I Study of the Safety and Adjunctive Effects of Psilocybin in Adults With Opioid Use Disorder Maintained on a Buprenorphine/Naloxone Formulation","normalized_title":"phase i study of the safety and adjunctive effects of psilocybin in adults with opioid use disorder maintained on a buprenorphine naloxone formulation","authors":"University of Wisconsin, Madison","abstract":"Primary Aim: In participants with OUD, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone formulation. Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of a buprenorphine-naloxone maintenance therapy. Secondary Aim: To evaluate the effect of concurrent buprenorphine-naloxone use on the effects of psilocybin therapy. Descriptive Aim: To describe any changes in self-efficacy, quality of life, pain. The primary objective of this clinical trial is to determine the safety of psilocybin in adult patients with opioid use disorder concurrently taking buprenorphine-naloxone. Eligible participants will be adults with active opioid use disorder (OUD) who are willing to begin and maintain a daily dose of buprenorphine-naloxone throughout study participation. Initiation, stabilization, and maintenance of buprenorphine-naloxone will be overseen by a qualified study medical provider. After psychological screening and at least 6 hours of preparatory counseling and preparation for the psilocybin dosing, set, and setting, each participant will ingest 1 oral dose of psilocybin. All dosing sessions will be attended by 2 specially trained facilitators, in a dedicated Clinical Research Facility. After eight hours of observation in the dosing room, the participant will be kept overnight in the hospital Clinical Research Unit, and complete an integration session with a psychologist before discharge to home. Approximately 4 weeks after the first dose, the participant will receive a second oral dose of psilocybin, with the same length of observation. Participants who have been administered the first dose but decline to receive the second dose will remain evaluable. At study termination, their active study participation will end, but completion of the 28 day post-dose follow up will be requested. The primary endpoint is the assessment of the safety of concurrent administration of a buprenorphine-naloxone formulation and psilocybin as determined by physiological measures (ECG, respiratory rate, blood pressure, body temperature, and blood oxygen saturation) and validated clinical and self-report measures (Clinical Opiate Withdrawal Scale (COWS), Opioid Craving Scale (OCS), Timeline Follow-Back (TLFB)). If you are interested in participating in this study, please fill out a brief 1-minute survey at the link in the \"More Information\" section at the bottom of this record.","journal":"ClinicalTrials.gov","publication_date":"2026-07-06","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT04161066","keywords":"Opioid Use Disorder, Psilocybin with facilitated counseling, RECRUITING","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:28","last_checked":"2026-07-09 01:22:31","raw_json":"{\"nct_id\":\"NCT04161066\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}","topic_tags":"Addiction,Chronic Pain,Clinical Trial,Observational Study,Safety,Adverse Events","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":3495,"title":"A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults","normalized_title":"a multicenter phase 1 safety and tolerability trial of psilocybin in healthy older adults","authors":"University of Colorado, Denver","abstract":"This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85. The purpose of this study is to learn whether psilocybin, a psychedelic compound, can be given safely to older adults. We want to understand how psilocybin affects the body and mind, including blood pressure, heart rhythm, and mood. We also want to see how the body processes psilocybin (how quickly it is absorbed and cleared) and whether it affects thinking, memory, or wellbeing. * Primary Objective: Evaluate the safety and tolerability of psychedelic administration in two cohorts of healthy older adults. * Cohort 1a Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart. * Cohort 1b Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart. * Secondary Objectives: Evaluate the pharmacokinetics of Psilocybin for each Cohort of healthy older adults. * Exploratory Objectives: Evaluate patient-reported outcomes related to Psilocybin administration (e.g., psychedelic experience and well-being) in each Cohort. Assess the relationships between the pharmacokinetic profile, safety endpoints, and patient-reported outcomes in each Cohort.","journal":"ClinicalTrials.gov","publication_date":"2026-07-05","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT07516405","keywords":"Healthy Volunteer, Older Adults (65-85 Years), Psilocybin (Usona Institute), RECRUITING","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:27","last_checked":"2026-07-09 01:22:31","raw_json":"{\"nct_id\":\"NCT07516405\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\"]}","topic_tags":"Pharmacology,Aging,Wellbeing,Clinical Trial,Observational Study,Healthy Volunteers,Older Adults,Safety","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":5672,"title":"Naturally Derived Psilocybin for Therapeutic Use: A Six-Criterion Framework for Evidence, Safety, and Benefit-Risk Considerations in Policy and Clinical Development","normalized_title":"naturally derived psilocybin for therapeutic use a six criterion framework for evidence safety and benefit risk considerations in policy and clinical development","authors":"Enriquez-Geppert Stefanie, Bevers Lisa, Rosander Arvid, Fodran Peter, Polito Vince","abstract":"Naturally derived psilocybin is widely used, yet its therapeutic potential, pharmacological distinctiveness and regulatory feasibility remain understudied. This review evaluates the potential of naturally derived psilocybin using a six-criterion framework to evaluate: (1) therapeutic benefit, (2) safety and tolerability, (3) pharmacological uniqueness vs. synthetic psilocybin, (4) identity and composition control, (5) dose precision and stability, and (6) ecological sustainability. This paper answers three key questions about naturally derived psilocybin: Does it show therapeutic potential? Does it differ from synthetic psilocybin? Can it meet medicinal standards? Findings suggest perceived therapeutic benefits from naturally derived psilocybin across mental health domains, though evidence of causal efficacy is mixed. Safety profiles are favorable but context-dependent, with risks in vulnerable populations. Some preliminary preclinical evidence indicates possible entourage effects, but human validation is lacking. Dose precision varies, with purified psilocybin being most reliable, followed by standardized extracts, alcoholic, aqueous, and whole biomass preparations. Scalable cultivation is feasible but faces sustainability challenges. Key gaps include a lack of controlled trials, longitudinal safety evaluations, and standardization. We provide a phased research roadmap, which proposes short-term studies to establish safety, mid-term mechanistic and standardization efforts, and long-term integration into therapeutic, cultural, and ecological systems. This review highlights the promise of naturally derived psilocybin but underscores the need for rigorous evidence to support regulatory acceptance and clinical use.","journal":"Biomolecules","publication_date":"2026-07-02","publication_year":2026,"doi":"10.3390/biom16070983","pubmed_id":null,"source_url":"https://doi.org/10.3390/biom16070983","keywords":"","substance_tags":"psilocybin","source_name":"Crossref","date_added":"2026-07-05 01:20:15","last_checked":"2026-07-09 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Enriquez-Geppert\",\"orcid\":\"https://orcid.org/0000-0001-7305-0111\"},{\"id\":\"https://openalex.org/A5139990795\",\"display_name\":\"Lisa Bevers\",\"orcid\":null},{\"id\":\"https://openalex.org/A5139974022\",\"display_name\":\"Arvid Rosander\",\"orcid\":null},{\"id\":\"https://openalex.org/A5079289829\",\"display_name\":\"Peter Fodran\",\"orcid\":\"https://orcid.org/0000-0003-0348-8331\"},{\"id\":\"https://openalex.org/A5045686739\",\"display_name\":\"Vince Polito\",\"orcid\":\"https://orcid.org/0000-0003-3242-9074\"}],\"primary_location\":{\"source_id\":\"https://openalex.org/S4210236520\",\"source_display_name\":\"Biomolecules\",\"landing_page_url\":\"https://doi.org/10.3390/biom16070983\",\"is_oa\":true}}}","topic_tags":"Review Article,Animal Study,Safety","study_type":"Review Article","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":"https://openalex.org/W7167239267"},{"id":3976,"title":"Psilocybin as a Transdiagnostic Treatment for Eating Disorders and Comorbid Psychopathology: Implications for Clinical Nosology and Research Directions.","normalized_title":"psilocybin as a transdiagnostic treatment for eating disorders and comorbid psychopathology implications for clinical nosology and research directions","authors":"Koning E, Richard J, Keshen A.","abstract":"ObjectiveEating disorders (EDs) are characterized by high rates of psychiatric comorbidity and suboptimal treatment outcomes. There remain critical gaps in research, including the exploration of effective transdiagnostic interventions. This forum article examines the potential of psilocybin treatment (PT) as a transdiagnostic intervention for EDs and common comorbidities, including the implications for alternative nosological frameworks, trial design, and clinical care.MethodA narrative review was conducted synthesizing clinical, mechanistic, and conceptual literature on PT for EDs and common psychiatric comorbidities. Searches of academic databases were supplemented by hand-searching and clinical trial registries. Thematic synthesis focused on transdiagnostic clinical evidence, mechanistic theories, and implications for the Hierarchical Taxonomy of Psychopathology (HiTOP), Research Domain Criteria (RDoC), treatment development, and clinical trial design.ResultsPreliminary clinical evidence supports the feasibility, safety, and therapeutic effects of PT for EDs, with robust transdiagnostic effects observed across comorbid conditions. Proposed mechanisms (i.e., serotonergic receptor agonism, psychoplastogenic effects, neural network desynchronization) target shared vulnerabilities that map onto dimensional constructs in HiTOP (Emotional Dysfunction superspectrum, Internalizing spectrum) and RDoC (negative/positive valence, cognitive, and social process domains) nosologies. Future research should explore pragmatic trial designs and dimensional outcome measures to capture the real-world complexities of PT for EDs.DiscussionPT demonstrates transdiagnostic therapeutic potential for EDs, and the advancement of dimensional nosologies, complex intervention frameworks, and personalized treatment protocols may address existing gaps in research and clinical care.","journal":"International Journal of Eating Disorders","publication_date":"2026-07-01","publication_year":2026,"doi":"10.1002/eat.70164","pubmed_id":"42393007","source_url":"https://doi.org/10.1002/eat.70164","keywords":"","substance_tags":"psilocybin","source_name":"Europe PMC","date_added":"2026-07-04 01:20:05","last_checked":"2026-07-09 01:20:16","raw_json":"{\"europe_pmc_id\":\"42393007\",\"source\":\"MED\",\"pub_type\":null,\"publisher\":null,\"importer\":\"Europe 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\":\"Elena Koning\",\"orcid\":\"https://orcid.org/0000-0001-5241-0288\"},{\"id\":\"https://openalex.org/A5006203775\",\"display_name\":\"Jérémie Richard\",\"orcid\":\"https://orcid.org/0000-0001-9893-1353\"},{\"id\":\"https://openalex.org/A5023552725\",\"display_name\":\"Aaron Keshen\",\"orcid\":\"https://orcid.org/0000-0003-0462-9749\"}],\"primary_location\":{\"source_id\":\"https://openalex.org/S74080386\",\"source_display_name\":\"International Journal of Eating Disorders\",\"landing_page_url\":\"https://doi.org/10.1002/eat.70164\",\"is_oa\":false}}}","topic_tags":"Eating Disorders,Mechanism of Action,Receptor Pharmacology,Emotional Processing,Clinical Trial,Review Article,Safety","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":"https://openalex.org/W7167014213"},{"id":3662,"title":"Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms","normalized_title":"efficacy in relapse prevention psilocybin in alcohol use disorder with depressive symptoms","authors":"Centre Hospitalier Universitaire de Nīmes","abstract":"Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. No treatments have been approved for individuals with both AUD and depression. Psilocybin, a psychedelic, shows promising results in treating both depression and addiction. It may be particularly effective for preventing relapse in people with AUD who also have depressive symptoms after detoxification, offering quicker action than traditional antidepressants. The Psilocybin Alcohol Depression (PAD) pilot study, launched in February 2024, has provided critical insights for avoiding methodological flaws and demonstrated that psilocybin-assisted psychotherapy (PAP) is both feasible and acceptable. Preliminary efficacy analyses were conducted: at 12 weeks, the 25 mg group showed significantly greater reductions in drinking days (p = 0.038) and craving frequency (p = 0.045). Relapse rates were 35% in the 25 mg group and 50% in the control group (HR = 0.52 \\[0.16-1.65\\]). In the ERPPAD trial, the study authors will compare high-dose PAP with low-dose PAP in preventing relapse in individuals with AUD and depressive symptoms. The hypothesis is that high-dose PAP will be more effective than low-dose in preventing relapse over 6 months.","journal":"ClinicalTrials.gov","publication_date":"2026-06-30","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT07638553","keywords":"Alcohol Use Disorder, Depressive Sympotoms, Psilocybin, Psilocybin (high dose), Psilocybin (low dose), RECRUITING","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:28","last_checked":"2026-07-07 01:23:04","raw_json":"{\"nct_id\":\"NCT07638553\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE3\"]}","topic_tags":"Depression,Addiction,Safety","study_type":"Other","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":3547,"title":"A Phase 2, Open-Label Study Investigating the Safety and Efficacy of Psilocybin-Assisted Therapy for Sexual Assault-Related Posttraumatic Stress Disorder (PTSD)","normalized_title":"a phase 2 open label study investigating the safety and efficacy of psilocybin assisted therapy for sexual assault related posttraumatic stress disorder ptsd","authors":"Sunstone Medical","abstract":"A Phase 2, Open-Label Study to explore the efficacy, safety, and tolerability of psilocybin-assisted therapy in women with sexual assault-related Posttraumatic Stress Disorder (PTSD).","journal":"ClinicalTrials.gov","publication_date":"2026-06-30","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT06902974","keywords":"Post Traumatic Stress Disorder, PTSD, Psilocybin 25 mg, Psilocybin-assisted therapy, RECRUITING","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:28","last_checked":"2026-07-07 01:23:04","raw_json":"{\"nct_id\":\"NCT06902974\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}","topic_tags":"PTSD,Clinical Trial,Safety","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":107,"title":"Implementing psilocybin-assisted therapy in palliative care settings: A survey of stakeholders.","normalized_title":"implementing psilocybin assisted therapy in palliative care settings a survey of stakeholders","authors":"Plourde L, Chang SL, Nguyen O, Garel N, Farzin H, Stephan JF, Fallu JS, Dorval M, P3A Research Group","abstract":"While the adoption of psilocybin-assisted therapy for existential distress offers promising support for patients with life-threatening illnesses, implementing this intervention into palliative care settings presents significant real-world challenges. To examine palliative care stakeholders' knowledge and attitudes regarding psilocybin-assisted therapy, and identify barriers and facilitators to its implementation. We conducted a cross-sectional online survey between April 15 and December 18, 2024. The survey assessed perceived knowledge, attitudes, and perceived barriers and facilitators to the effective integration of psilocybin-assisted therapy into palliative care settings. One hundred and twenty-one adults involved in palliative care (physicians, other healthcare professionals, caregivers, and managers) were recruited from Canada's four most populous provinces: Québec, Ontario, Alberta, and British Columbia. Forty-three percent of stakeholders reported having good knowledge of psilocybin's potential benefits and risks. Attitudes towards psilocybin-assisted therapy were predominantly non-favourable (61%), yet varied across occupational groups ( Translating the potential of psilocybin-assisted therapy for existential distress from clinical trials into palliative care settings requires careful consideration and collaboration with stakeholders. Given the significant divergence in perspectives between clinical and non-clinical groups, tailored interprofessional education could help build shared understanding and support effective implementation. Being conducted in Canada, transferability to different regulatory frameworks may be limited.","journal":"Palliative medicine","publication_date":"2026-06-30","publication_year":2026,"doi":"10.1177/02692163261446141","pubmed_id":"42154482","source_url":"https://pubmed.ncbi.nlm.nih.gov/42154482/","keywords":"attitude of health personnel, hallucinogens, palliative care, psilocybin, surveys and questionnaires","substance_tags":"psilocybin","source_name":"PubMed","date_added":"2026-06-30 22:38:07","last_checked":"2026-07-08 01:20:05","raw_json":"{\"pubmed_id\":\"42154482\"}","topic_tags":"End-of-Life Distress,Clinical Trial,Observational Study,Safety","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":null},{"id":303,"title":"Study Protocol for \"Exploring the safety and therapeutic potential of psilocybin in the treatment of anorexia nervosa in adolescents and young adults\".","normalized_title":"study protocol for exploring the safety and therapeutic potential of psilocybin in the treatment of anorexia nervosa in adolescents and young adults","authors":"Sjöström D, Schau Rybäck O, Claesdotter Knutsson E, Kajonius P, Jensen Sondén O, Carlbring P, Björkstrand J, Movahed Rad P.","abstract":"BackgroundAnorexia nervosa (AN) is a severe psychiatric disorder with high morbidity, mortality, and relapse rates, most commonly emerging during adolescence. Despite specialized psychological and nutritional treatments, outcomes remain suboptimal, with high rates of relapse and chronicity. Psilocybin has been investigated with preliminary efficacy in other psychiatric conditions characterized by rigidity and treatment resistance, but clinical evidence in AN-particularly in adolescents-is limited.ObjectiveThe psiAN study aims to evaluate the safety, tolerability, and feasibility of psilocybin therapy combined with psychological support in adolescents and young adults with relapsing AN, while exploring clinical, experiential, and neurobiological correlates of change.MethodsA phase IIa, open-label, randomized controlled trial enrolling individuals aged 16-35 years with DSM-5 AN and a history of relapse. Participants are randomized to receive either two administrations of psilocybin (25 mg) with manualized psychological support plus treatment as usual (TAU), or TAU alone. Primary outcomes focus on safety and tolerability, assessed through adverse events, psychiatric monitoring, and medical parameters measured from first dosing to primary endpoint. Secondary outcomes include change in eating disorder symptom severity, relapse composite measures, mood, well-being, personality traits from baseline to primary endpoint with follow-up to 12 months. Functional magnetic resonance imaging (fMRI) and peripheral brain-derived neurotrophic factor are included as exploratory mechanistic measures. fMRI will evaluate pre- to post-intervention changes in structural and functional connectivity and task-related responses during a simplified Monetary Incentive Delay task (MIDT) and a Calorie-Cue Task (CCT). ClinicalTrials.gov Identifier: NCT07169747.Ethics and disseminationThe study follows Good Clinical Practice (GCP), the Declaration of Helsinki, and EU Clinical Trials Regulation requirements, with staged inclusion of adolescents (16-17-year-olds) after a safety board review of adult data (18-35-year-olds). This protocol was prepared with reference to the SPIRIT 2025 guidelines (Chan et al., 2025) to enhance transparency and inform future trials.","journal":"PLoS ONE","publication_date":"2026-06-29","publication_year":2026,"doi":"10.1371/journal.pone.0352246","pubmed_id":"42378255","source_url":"https://doi.org/10.1371/journal.pone.0352246","keywords":"Humans, Hallucinogens, Treatment Outcome, Anorexia Nervosa, Adolescent, Adult, Female, Randomized Controlled Trials as Topic, Clinical Trials, Phase II as Topic, Young Adult, Psilocybin","substance_tags":"psilocybin","source_name":"Europe PMC","date_added":"2026-07-01 06:48:03","last_checked":"2026-07-07 01:20:41","raw_json":"{\"europe_pmc_id\":\"42378255\",\"source\":\"MED\",\"pub_type\":null,\"publisher\":null,\"importer\":\"Europe 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Sjöström\",\"orcid\":\"https://orcid.org/0000-0003-0004-1892\"},{\"id\":\"https://openalex.org/A5073798116\",\"display_name\":\"Olea Schau Rybäck\",\"orcid\":null},{\"id\":\"https://openalex.org/A5111008178\",\"display_name\":\"Emma Claesdotter Knutsson\",\"orcid\":null},{\"id\":\"https://openalex.org/A5135752675\",\"display_name\":\"Petri Kajonius\",\"orcid\":null},{\"id\":\"https://openalex.org/A5139709727\",\"display_name\":\"Oskar Jensen Sondén\",\"orcid\":null},{\"id\":\"https://openalex.org/A5082635131\",\"display_name\":\"Per Carlbring\",\"orcid\":\"https://orcid.org/0000-0002-2172-8813\"},{\"id\":\"https://openalex.org/A5017431485\",\"display_name\":\"Johannes Björkstrand\",\"orcid\":\"https://orcid.org/0000-0002-1786-1064\"},{\"id\":\"https://openalex.org/A5018302853\",\"display_name\":\"Pouya Movahed\",\"orcid\":\"https://orcid.org/0000-0003-2041-3550\"}],\"primary_location\":{\"source_id\":\"https://openalex.org/S202381698\",\"source_display_name\":\"PLoS ONE\",\"landing_page_url\":\"https://doi.org/10.1371/journal.pone.0352246\",\"is_oa\":true}}}","topic_tags":"Eating Disorders,Brain Imaging,Aging,Wellbeing,Personality Change,Clinical Trial,Randomized Controlled Trial,Review Article,Adolescents,Safety,Adverse Events","study_type":"Randomized Controlled Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":"https://openalex.org/W7166779507"},{"id":3979,"title":"Naturally Derived Psilocybin for Therapeutic Use: A Six-Criterion Framework for Evidence, Safety, and Benefit-Risk Considerations in Policy and Clinical Development","normalized_title":"naturally derived psilocybin for therapeutic use a six criterion framework for evidence safety and benefit risk considerations in policy and clinical development","authors":"Stefanie Enriquez Geppert, Lisa Bevers, Arvid Rosander, Peter Fodran, Vince Polito","abstract":"","journal":"University of Groningen research database (University of Groningen / Centre for Information Technology)","publication_date":"2026-06-28","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://research.rug.nl/en/publications/370a82bd-d8db-4a02-b644-bf0c9131680b","keywords":"Psilocybin, Drug development, Psychology, Medicine, Psychotherapist, MEDLINE, Psychiatry, Clinical trial, Intensive care medicine, Perspective (graphical), Psychedelics and Drug Studies, Forensic Toxicology and Drug Analysis, Cannabis and Cannabinoid Research","substance_tags":"psilocybin","source_name":"OpenAlex","date_added":"2026-07-04 01:20:27","last_checked":"2026-07-06 01:20:37","raw_json":"{\"openalex_id\":\"https://openalex.org/W7167168218\",\"openalex_url\":\"https://openalex.org/W7167168218\",\"openalex_relevance_score\":6,\"openalex_relevance_reasons\":[\"title:psilocybin\",\"metadata:psilocybin\"],\"openalex_type\":\"article\",\"openalex_work_type\":null,\"cited_by_count\":0,\"referenced_works\":[],\"authorships\":[{\"id\":\"https://openalex.org/A5139873851\",\"display_name\":\"Stefanie Enriquez Geppert\",\"orcid\":null},{\"id\":\"https://openalex.org/A5139893961\",\"display_name\":\"Lisa Bevers\",\"orcid\":null},{\"id\":\"https://openalex.org/A5139856970\",\"display_name\":\"Arvid Rosander\",\"orcid\":null},{\"id\":\"https://openalex.org/A5079289829\",\"display_name\":\"Peter Fodran\",\"orcid\":\"https://orcid.org/0000-0003-0348-8331\"},{\"id\":\"https://openalex.org/A5045686739\",\"display_name\":\"Vince Polito\",\"orcid\":\"https://orcid.org/0000-0003-3242-9074\"}],\"primary_location\":{\"source_id\":\"https://openalex.org/S4306400420\",\"source_display_name\":\"University of Groningen research database (University of Groningen / Centre for Information Technology)\",\"landing_page_url\":\"https://research.rug.nl/en/publications/370a82bd-d8db-4a02-b644-bf0c9131680b\",\"is_oa\":false}}","topic_tags":"Clinical Trial,Safety,Toxicity","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":"https://openalex.org/W7167168218"},{"id":3561,"title":"The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease","normalized_title":"the efficacy of psilocybin therapy for depression in parkinson s disease","authors":"Yale University","abstract":"The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy. This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson's disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient population. Investigators will enroll participants with clinically diagnosed early to moderate stage Parkinson's disease (Hoehn and Yahr Stage 1-3 during an \"on\" period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. Participants will complete two drug administration sessions where they will each receive a dose of oral psilocybin ranging from low (\"microdose\") to high in a medically monitored setting with psychotherapeutic support. Participants will also complete a series of psychotherapy sessions before and after each drug administration session. Clinical assessments will be used to quantify changes in depression as well as other relevant outcomes (non-motor and motor symptoms of PD, cognitive performance, quality of life). Follow-up will continue to 3 months after the second session. Endpoints will evaluate efficacy, safety, and tolerability of study procedures. After posting of these trial results, this data will be combined with the data from the trial at UCSF (NCT06455293) for publication purposes.","journal":"ClinicalTrials.gov","publication_date":"2026-06-28","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT07610369","keywords":"Depression, Parkinson's Disease (PD), Psilocybin (drug), 4-phosphoryloxy- N, N-dimethyltryptamine, NOT_YET_RECRUITING","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:28","last_checked":"2026-07-05 01:22:40","raw_json":"{\"nct_id\":\"NCT07610369\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"PHASE2\"]}","topic_tags":"Depression,Microdosing,Randomized Controlled Trial,Safety","study_type":"Randomized Controlled Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":3621,"title":"Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder: An Open-label Trial","normalized_title":"psilocybin assisted massed cognitive processing therapy for chronic posttraumatic stress disorder an open label trial","authors":"Unity Health Toronto","abstract":"This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD). Current front-line treatments for Posttraumatic stress disorder (PTSD) are ineffective for up to half of patients, with serious medical and societal consequences. It is imperative to improve the efficacy of front-line treatment options, such as cognitive processing therapy (CPT). CPT is an effective treatment for PTSD, including when delivered intensively (i.e., multiple sessions over 7 days). However, a substantial proportion of patients continue to meet criteria for PTSD or have residual PTSD symptoms post-treatment. Psilocybin-assisted CPT may be a potential solution, as preliminary evidence supports the potential of psilocybin to alleviate symptoms of PTSD. Fifteen participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT, and 2 psychotherapy sessions related to psilocybin over 7 days. Participants will complete clinician-administered scales, self-reported mental health questionnaires, and use a wearable device. After the 1-week interventional period, participants will enter a 12-weeks follow-up period.","journal":"ClinicalTrials.gov","publication_date":"2026-06-25","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT06386003","keywords":"Post Traumatic Stress Disorder, PTSD, Chronic PTSD, Psilocybin, RECRUITING","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:28","last_checked":"2026-07-02 23:06:03","raw_json":"{\"nct_id\":\"NCT06386003\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}","topic_tags":"PTSD,Healthcare Workers,Safety","study_type":"Other","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":3522,"title":"Psilocybin-Assisted Therapy for Physician Well-Being and Burnout: Feasibility, Safety, Clinical Effectiveness and Biomarkers of Response [PAT-B (Psilocybin-Assisted Therapy for Physician Well-Being and Burnout)]","normalized_title":"psilocybin assisted therapy for physician well being and burnout feasibility safety clinical effectiveness and biomarkers of response pat b psilocybin assisted therapy for physician well being and burnout","authors":"University of California, San Diego","abstract":"Through an open-label study involving a small group of UCSD physicians experiencing burnout, the investigators will evaluate the feasibility, safety, and preliminary effectiveness of PAT to reduce burnout symptoms. Physician burnout is a critical issue. Research shows that physician burnout is increasing, that physicians suffer higher rates of burnout than the general population, and that physician burnout is associated with poor mental health outcomes. Psilocybin is a naturally occurring alkaloid within certain fungi that elicits acute perceptual, cognitive, and emotional changes when ingested, due to action on neurotransmitter and neurocirculatory systems. The combination of psilocybin with psychological support, termed Psilocybin-Assisted Therapy (PAT), is a promising new mental health intervention shown to produce rapid and sustained improvements in psychological domains affected in burnout. PAT demonstrates preliminary efficacy as a treatment for depression and substance use disorders, is associated with brain changes measured with electroencephalography (EEG) and is a strong candidate treatment for physician burnout. The primary aim of this study is to investigate the safety, feasibility, and preliminary efficacy of PAT to enhance well-being in University of California, San Diego (UCSD) physicians experiencing burnout. A secondary aim is to identify neurophysiological changes associated with response to PAT. Physicians experiencing burnout will be recruited in an open-label trial involving preparatory therapy sessions, psilocybin treatment, and post-treatment integration. Burnout will be measured with the Stanford Professional Fulfillment Index (PFI).","journal":"ClinicalTrials.gov","publication_date":"2026-06-25","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT06814522","keywords":"Burnout, Burnout, Healthcare Workers, Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate, Psilocybin, RECRUITING","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:27","last_checked":"2026-07-02 23:06:03","raw_json":"{\"nct_id\":\"NCT06814522\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE1\",\"PHASE2\"]}","topic_tags":"Depression,Addiction,Brain Imaging,Biomarkers,Wellbeing,Emotional Processing,Healthcare Workers,Safety","study_type":"Other","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":3595,"title":"Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects","normalized_title":"acute effects of mdma co administration on the response to psilocybin in healthy subjects","authors":"University Hospital, Basel, Switzerland","abstract":"The acute subjective effects of serotonin (5-HT)2A receptor stimulation with psilocybin in humans are mostly positive. However, negative effects such as anxiety, paranoid thinking, or loss of trust towards other people are common effects, depending on the dose administered, the personality traits of the person consuming it (set), or the environment in which psilocybin is taken (setting). Negative psychedelic effects may cause acute distress to the subject and acute anxiety has been linked to less favorable long-term outcomes in patients experimentally treated with psilocybin or similar substances for the treatment of depression. The 5-HT and oxytocin releaser 3,4-methylenedioxymethamphetamine (MDMA) reliably induces positive mood, euphoria, comfort, empathy, and feelings of trust. If administered in combination with psilocybin, MDMA may increase positive subjective drug effects including positive mood, empathy, and trust and reduce negative emotions and anxiety associated with psilocybin and overall produce a more positive over negative experience. The present study will assess subjective and autonomic effects of psilocybin alone and in combination with MDMA. Psilocybin is a classic serotonergic psychedelic. Clinically, the acute effects of psilocybin last shorter than those of lysergic acid diethylamide (LSD) but are qualitatively very similar. Currently, psilocybin is the most investigated psychedelic substance among the classic psychedelics including LSD, psilocybin, mescaline, and dimethyltryptamine (DMT). Psilocybin is capable of inducing exceptional subjective effects such as a dream-like alteration of consciousness, affective changes, psychological insight, visual imagery, pseudo-hallucinations and ego-dissolution. The acute subjective effects elicited by psilocybin are mostly positive in humans. However, psychedelic substances like psilocybin may also cause unpleasant subjective effects like negative thoughts, rumination, anxiety, panic, paranoia, loss of trust towards other people and perceived loss of control, depending on the dose of psilocybin used, the personality traits of the person consuming it (i.e. 'set'), the environment in which it is consumed (i.e. 'setting'), and other factors. Acute negative psychological effects are considered the main risk of psychedelic substance use in humans. Inducing an overall positive acute response to the psychedelic is critical because several studies showed that a more positive experience is predictive of a greater therapeutic long-term effect of the psychedelic. The present study uses 3,4-methylenedioxymethamphetamine (MDMA) as a pharmacological tool to optimize the effects of psilocybin by inducing positive mood. MDMA is an amphetamine derivative which, unlike prototypical amphetamines, predominantly enhances serotonergic neurotransmission via release of 5-HT through the serotonin transporter (SERT). Furthermore, MDMA is known to trigger oxytocin release which may contribute to its effects to increase trust, prosociality, and enhanced empathy. The state of well-being induced by MDMA including increased activation and emotional excitation is known to be associated with a better response to psychedelics. Due to its psychological profile, MDMA could be a reliable pharmacological tool to serve as an optimizer of a psychedelic experience by inducing positive emotions.","journal":"ClinicalTrials.gov","publication_date":"2026-06-24","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT06884514","keywords":"Healthy, Psilocybin, 3,4-Methylenedioxymethamphetamine, Psilocybin placebo, 3,4-Methylenedioxymethamphetamine placebo, COMPLETED","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:28","last_checked":"2026-07-01 23:13:10","raw_json":"{\"nct_id\":\"NCT06884514\",\"overall_status\":\"COMPLETED\",\"phase\":[\"PHASE1\"]}","topic_tags":"Depression,Anxiety,Addiction,Receptor Pharmacology,Consciousness,Wellbeing,Personality Change,Emotional Processing,Safety","study_type":"Qualitative Study","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":30,"title":"The intersection between psychedelics and schizophrenia spectrum disorders: Reevaluating risk and therapeutic potential.","normalized_title":"the intersection between psychedelics and schizophrenia spectrum disorders reevaluating risk and therapeutic potential","authors":"Brar PS, Price RB, Ross S, Tofighi B, Sarpal DK","abstract":"In the past decade, interest in studying psychedelic compounds as potential therapeutic agents has resurged. These studies carefully exclude individuals at risk for developing psychotic symptoms in response to psychedelic use. Given the potential for psychedelics to be established as treatments in psychiatry, it is important to more robustly understand their link with psychosis and schizophrenia spectrum disorders (SSDs). In this narrative review, we examine the historical and theoretical relationship between psychedelic drugs and SSDs, including the origins of the psychotomimetic hypothesis. For key psychedelic compounds, we review their phenomenological manifestations in relation to the experiential alterations characteristic of SSDs, revealing both areas of overlap and important qualitative differences that challenge the uniform psychotomimetic classification. We also review putative neural mechanisms underlying altered experiential states associated with psychedelic use and SSDs, with attention to serotonergic, dopaminergic, and glutamatergic contributions. Clinical evidence demonstrates that psychedelics can exacerbate pre-existing psychotic illness and may trigger psychosis in vulnerable individuals, though the magnitude of these risks remains inadequately quantified. However, phenomenological and mechanistic distinctions suggest that potential therapeutic applications may exist for carefully selected symptoms (negative symptoms, depression) in stable patients using low-dose, controlled approaches. Based on published work, we provide recommendations regarding psychosis-related risk and potential avenues for the treatment of SSDs as psychedelics gain traction as therapeutics.","journal":"Journal of psychopharmacology (Oxford, England)","publication_date":"2026-06-24","publication_year":2026,"doi":"10.1177/02698811261456191","pubmed_id":"42345450","source_url":"https://pubmed.ncbi.nlm.nih.gov/42345450/","keywords":"DMT, LSD, mescaline, phenomenology, psilocybin, psychedelics, psychosis, schizophrenia","substance_tags":"psilocybin","source_name":"PubMed","date_added":"2026-06-30 22:38:07","last_checked":"2026-07-02 23:03:18","raw_json":"{\"pubmed_id\":\"42345450\"}","topic_tags":"Depression,Mechanism of Action,Review Article,Safety","study_type":"Review Article","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":null},{"id":3684,"title":"TRIP - TReatment to Improve Depression and/or Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy","normalized_title":"trip treatment to improve depression and or anxiety using psilocybin assisted psychotherapy in patients with advanced cancer on maintenance therapy","authors":"M.D. Anderson Cancer Center","abstract":"To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer. Primary Objective To examine the feasibility, safety, effect size estimates of psilocybin-assisted psychotherapy for participants with depression and/or anxiety who are being actively treated for advanced cancer. Feasibility will be measured as: At least 20% of eligible participants consent and at least 60% of consented participants complete the two doses of treatment. Secondary Objectives 1. Determine whether psilocybin-assisted psychotherapy improves measures of quality of life (e.g., sleep, pain, functional status) and psychosocial well-being (e.g., finding meaning and post-traumatic growth), as measured by the following: PHQ-9, GAD-7, PROMIS-10, PROMIS-A, PROMIS-D, MEQ30 (mystical experience), Flourishing scale, mDES, 5D-ASC (altered states), and Posttraumatic Growth Inventory. 2. Determine whether psilocybin-assisted psychotherapy improves functional status per clinician-rated outcome measures. 3. Assess the effects of psilocybin-assisted psychotherapy on cancer treatment adherence determined by the likelihood that participants will follow the prescribed treatment (adherence) and continue the treatment for the duration prescribed (persistence) for these maintenance therapies. 4. Measure the change in inflammatory markers (IL6, TNF, and CRP) and in frequency and activation status of peripheral immune cell populations assessed by immune monitoring through flow cytometry. 5. Examine changes in central nervous system plasticity through the use of fMRI, specifically changes in 5-HT2A-rich and higher-order functional networks, as well as a global increase in brain network integration. 6. Evaluate the Impact on MDASI measurements.","journal":"ClinicalTrials.gov","publication_date":"2026-06-23","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT06200155","keywords":"Depression, Anxiety, Psilocybin-Assisted Psychotherapy, Advanced Cancer, Psilocybin, Niacin, RECRUITING","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:28","last_checked":"2026-07-01 11:22:34","raw_json":"{\"nct_id\":\"NCT06200155\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}","topic_tags":"Depression,Anxiety,Chronic Pain,Neuroplasticity,Brain Imaging,Receptor Pharmacology,Biomarkers,Wellbeing,Mystical Experience,Healthcare Workers,Safety,Inflammation,Immune Function","study_type":"Other","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":3674,"title":"TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors","normalized_title":"trips treatment to improve depression and or anxiety using psilocybin assisted psychotherapy in cancer survivors","authors":"M.D. Anderson Cancer Center","abstract":"This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety. Primary Objective: To examine the feasibility, safety, effect size estimates of psilocybin-assisted psychotherapy for cancer survivor patients with depression and/or anxiety. Feasibility will be measured as: At least 20% of eligible patients consent (inclusion rate), at least 60% of consented patients completing the two doses of treatment (treatment completion rate), and at least 80% and 65% consenting patients completing assessments at the 2- and 6-month follow-ups (adherence rates), respectively. Secondary Objectives: 1. Determine whether psilocybin-assisted psychotherapy improves measures of quality of life (e.g., sleep, pain, functional status) and psychosocial well-being (e.g., finding meaning and post-traumatic growth), as measured by the following: PHQ-9, GAD-7, PROMIS-10, PROMIS-A, PROMIS-D, MEQ30 (mystical experience), Flourishing scale, mDES, PIQ (altered states), and Posttraumatic Growth Inventory. 2. Determine whether psilocybin-assisted psychotherapy improves functional status per clinician-rated outcome measures. 3. Measure the change in inflammatory markers (IL6, TNF, and CRP) and in frequency and activation status of peripheral immune cell populations assessed by immune monitoring through flow cytometry. 4. Examine changes in central nervous system plasticity through the use of fMRI, specifically changes in 5-HT2A-rich and higher-order functional networks, as well as a global increase in brain network integration. 5. Evaluate the Impact on MDASI measurements.","journal":"ClinicalTrials.gov","publication_date":"2026-06-23","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT06801041","keywords":"Depression, Anxiety, Cancer, Psilocybin, RECRUITING","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:28","last_checked":"2026-07-01 11:22:34","raw_json":"{\"nct_id\":\"NCT06801041\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}","topic_tags":"Depression,Anxiety,Chronic Pain,Neuroplasticity,Brain Imaging,Receptor Pharmacology,Biomarkers,Wellbeing,Mystical Experience,Healthcare Workers,Safety,Inflammation,Immune Function","study_type":"Other","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":3705,"title":"Effects of Psilocybin Microdosing on Cognition, Mood and Quality of Life: A Pilot Study","normalized_title":"effects of psilocybin microdosing on cognition mood and quality of life a pilot study","authors":"Yale University","abstract":"This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural/functional MRI results compared to a placebo. Investigators hypothesize that compared to placebo, 30 days of intermittently microdosed psilocybin will produce observable changes in mood, cognition, subjective well-being and MRI, in the absence of psychedelic experiences. This study is being conducted to evaluate the effects of 30 days of intermittently microdosed psilocybin in a parallel arm double-blind manner on mood, cognition, subjective well-being and structural/functional MRI compared to placebo, using validated psychological assessments and cognitive tests. Investigators hypothesize that compared to placebo, 30 days of intermittently microdosed psilocybin will produce observable changes in mood, cognition, subjective well-being and MRI, in the absence of psychedelic experiences. Demonstrating significant results in a population of healthy psychedelic non-users will establish a strong precedent for studying the effects of microdosing psychedelics in patient populations, such as those with treatment-resistant depression. Showing that microdosing minimizes risk of adverse outcomes with psychedelic treatment while maintaining beneficial effects would provide useful information relevant to clinical research in psychedelic-assisted psychotherapy. In addition to investigating claims that microdosing psychedelics may improve cognition and mood, this study also aims to test the hypothesis that these effects including those measurable at a brain level may persist beyond the course of the 30 days of the study. There are few to no studies that assessed the longevity of psychedelic effects on the majority of the above measures, so the proposed study may further establish the longer-term benefits of microdosing. The use of structural and functional magnetic resonance imaging (fMRI) will elucidate the mechanisms by which microdosing may be exerting its effects on mood and cognition. Because this is a relatively understudied area, information gleaned from this study will provide service in informing the field in general.","journal":"ClinicalTrials.gov","publication_date":"2026-06-22","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT07449351","keywords":"Psychedelic Microdosing Effects on Mood, Cognition, Subjective Well-being and MRI, Psliocybin, Placebo, NOT_YET_RECRUITING","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:28","last_checked":"2026-07-01 11:22:34","raw_json":"{\"nct_id\":\"NCT07449351\",\"overall_status\":\"NOT_YET_RECRUITING\",\"phase\":[\"EARLY_PHASE1\"]}","topic_tags":"Depression,Brain Imaging,Mechanism of Action,Aging,Longevity,Microdosing,Wellbeing,Treatment-Resistant Depression,Safety","study_type":"Other","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":3650,"title":"Psilocybin-assisted Existential, Attachment and Relational (PEARL) Therapy for Caregivers of Patients With Advanced Cancer: A Phase II Open-Label Trial","normalized_title":"psilocybin assisted existential attachment and relational pearl therapy for caregivers of patients with advanced cancer a phase ii open label trial","authors":"University Health Network, Toronto","abstract":"The PEARL-C1 trial is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. Caregivers of patients with advanced cancer often experience high levels of distress but there is currently little evidence-based guidance on how to help caregivers who experience depression, anxiety, anticipatory grief, spiritual suffering, caregiving burden and/or impaired quality of life. Over the past decade, research has shown that psychotherapies incorporating existential, attachment and relational approaches can address the specific needs and challenges of the advanced cancer population and thus help to reduce related distress. Simultaneously, recent research has shown that psilocybin-assisted psychotherapy, in which an individual ingests the psychoactive drug within a carefully monitored therapy, can reduce end-of-life distress and greatly benefit those with advanced disease. The multidisciplinary team has combined these two evidence-based approaches into Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. PEARL therapy combines elements from psilocybin-assisted psychotherapy, including preparatory therapy sessions, a high-dose drug session, and integration sessions, with important elements from manualized individual psychotherapies designed for patients and their families facing advanced cancer. This study will assess the feasibility, acceptability, and safety of PEARL therapy among caregivers of patients with advanced cancer. This study will contribute to the growing research around the efficacy of psychedelic-assisted therapies for the psychological distress associated with advanced disease and mortality. This type of therapy has the potential to improve quality of life among caregivers of those with advanced disease, to build upon previous findings to help outline the necessary components of therapy, and to inform public policy and clinical guidelines.","journal":"ClinicalTrials.gov","publication_date":"2026-06-22","publication_year":2026,"doi":null,"pubmed_id":null,"source_url":"https://clinicaltrials.gov/study/NCT07048743","keywords":"Caregiver Distress, Psilocybin, RECRUITING","substance_tags":"psilocybin","source_name":"ClinicalTrials.gov","date_added":"2026-07-01 11:04:28","last_checked":"2026-07-01 11:22:34","raw_json":"{\"nct_id\":\"NCT07048743\",\"overall_status\":\"RECRUITING\",\"phase\":[\"PHASE2\"]}","topic_tags":"Depression,Anxiety,End-of-Life Distress,Spirituality,Clinical Trial,Safety","study_type":"Clinical Trial","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"clinical trial","openalex_id":null},{"id":33,"title":"Cardiovascular effects associated with acute recreational drug toxicity presentations to the emergency department: a European drug emergencies network (Euro-DEN plus) study.","normalized_title":"cardiovascular effects associated with acute recreational drug toxicity presentations to the emergency department a european drug emergencies network euro den plus study","authors":"van den Busken WJ, Dines AM, Eyer F, Heyerdahl F, Hovda KE, Liechti ME, Miró Ò, Vallersnes OM, Wood DM, Yates C, Dargan PI, (on behalf of the Euro-DEN Plus Research Group), Gresnigt FMJ, Euro-DEN Plus Research Group","abstract":"Recreational drugs affect the cardiovascular system through distinct mechanisms; however, data regarding their cardiovascular impact in the emergency department setting is limited. This study aimed to assess the incidence of cardiovascular effects following recreational drug use in presentations to the emergency department, identify the main drug groups involved, and compare cases with and without cardiovascular effects. Data were extracted from the European Drug Emergency Network (Euro-DEN Plus) dataset from October 2013 to December 2021. Recreational drugs were categorised into ten main drug groups: opioids, cocaine, crack cocaine, cannabis, 3,4-methylenedioxymethamfetamine, amfetamine-type stimulants, gamma-hydroxybutyrate and gamma-butyrolactone, hallucinogens, benzodiazepines, and ketamine. Among 59,571 presentations, 13,905 (23.3%) involved cardiovascular effects. Cocaine (OR3.19, 95% CI2.99-3.39) and 3,4 methylenedioxymethamphetamine (OR1.18, 95% CI1.13-1.23) showed the strongest associations with cardiovascular features, including chest pain, palpitations, hypertension, and arrhythmias. Opioids (OR0.35, 95% CI0.31-0.38) and benzodiazepines (OR0.38, 95% CI0.32-0.44) were associated with less frequent cardiovascular features. Patients with cardiovascular features exhibited higher median values for temperature, heart rate, blood pressure, and respiratory rate (p Cardiovascular effects were common in acute recreational drug toxicity. Cocaine and amfetamine-type stimulants increased the risk of chest pain and arrhythmias, with chest pain being a key indicator of acute coronary syndrome. Cardiovascular effects were more frequently observed with cocaine than with crack cocaine. Cannabis was positively associated with palpitations but not arrhythmias. Gamma-hydroxybutyrate and gamma-butyrolactone, opioids, and benzodiazepines were linked to hypotension. The presence of cardiovascular effects was associated with worse outcomes, underscoring the need for thorough cardiac assessment. Cardiovascular effects were present in almost a quarter of emergency department presentations with acute recreational drug toxicity, particularly involving cocaine and 3,4 methylenedioxymethamphetamine.","journal":"Clinical toxicology (Philadelphia, Pa.)","publication_date":"2026-06-22","publication_year":2026,"doi":"10.1080/15563650.2026.2669671","pubmed_id":"42334445","source_url":"https://pubmed.ncbi.nlm.nih.gov/42334445/","keywords":"3,4 methylenedioxymeth­amphetamine, acute drug toxicity, amfetamine, amfetamine (amphetamine), amphetamine, cardio­vascular, cocaine, lysergide (lyseric acid diethylamide), midamafetamine (3,4 methylenedioxymethamphetamine, midomafetamine, psilocybine (psilocybin)","substance_tags":"psilocybin","source_name":"PubMed","date_added":"2026-06-30 22:38:07","last_checked":"2026-07-01 11:20:34","raw_json":"{\"pubmed_id\":\"42334445\"}","topic_tags":"Addiction,Chronic Pain,Mechanism of Action,Safety,Toxicity","study_type":"Other","hidden":0,"false_positive":0,"curation_notes":null,"merged_into_id":null,"curation_locked":0,"publication_status":"published","openalex_id":null}],"total":925,"page":1,"per_page":20,"pages":47,"resource":"papers","filters":{"q":null,"author":null,"substances":["psilocybin","psilocin"],"topic":"Safety","study_type":null,"cited_doi":null,"sources":[],"publication_statuses":[],"year":null,"journal":null,"from":null,"to":null,"added_from":null,"added_to":null,"sort":"newest","page":1,"per_page":"20"}}