Breakthrough Therapy Designations: Psilocybin has received Breakthrough Therapy designation multiple times (Compass Pathways, Usona, Cybin).
Key Studies:
Single-Dose Psilocybin Treatment for MDD: A Randomized Clinical Trial (JAMA Psychiatry, Aug 2023)
Psilocybin for Treatment-Resistant Depression in Patients Taking a Concomitant SSRI medication (Neuropharmacology, July 2023)
Psilocybin-assisted Therapy for Major Depressive Disorder: An exploratory placebo-controlled, fixed-order trial (Journal of Psychopharmacology, March 2023)
Single-dose Psilocybin-assistedTherapy in Major Depressive Disorder: A Placebo-controlled, Double-blind, Randomised ClinicalTrial (EClinicalMedicine, Dec 2022)
Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression (NEJM, Nov 2022)
Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder (JAMA Psychiatry, Nov 2020)
Psilocybin with Psychological Support for Treatment-Resistant Depression: an Open-Label Feasibility Study (Lancet Psychiatry, May 2016)
Durability of Effects:
Efficacy and Safety of Psilocybin-Assisted Treatment of Major Depressive Disorder: Prospective 12-month Follow-Up (Journal of Psychopharmacology, Feb 2022)
Psilocybin with Psychological Support for Treatment-Resistant Depression: 6-month Follow-Up (Psychopharmacology, Nov 2017)
Comparison to Antidepressants:
Trial of Psilocybin vs Escitalopram for Depression (NEJM, April 2021)
Ongoing Trials: 16 ongoing/planned trials, including two Phase III trials (Compass, Usona). Potential FDA approval 2026/2027.
Key Studies:
HOPE: A Pilot Study of Psilocybin-Enhanced Group Psychotherapy in Patients with Cancer (J of Pain & Symptom Management, June 2023)
Acute & Sustained Reductions in Loss of Meaning & Suicidal Ideation Following Psilocybin-Assisted Psychotherapy for Psychiatric & Existential Distress in Life-Threatening Cancer (Academic Psychiatry, March 2021)
Long-Term Follow-Up of Psilocybin-Assisted Psychotherapy for Psychiatric & Existential Distress in Patients with Life-Threatening Cancer (J of Psychopharmacology, Jan 2020)
Rapid & Sustained Symptom Reduction Following Psilocybin Treatment for Anxiety & Depression in Patients with Life-Threatening Cancer: A Randomized Controlled Trial (J of Psychopharmacology, Nov 2016)
Psilocybin Produces Substantial and Sustained Decreases in Depression & Anxiety in Patients with Life-Threatening Cancer: A Randomized Double-Blind Trial (J of Psychopharmacology, Nov 2016)
Pilot Study of Psilocybin Treatment for Anxiety in Patients with Advanced-Stage Cancer (Archives of General Psychiatry, 2010)
Ongoing Trials: 11 ongoing/planned trials.
Key Studies:
Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients with Alcohol Use Disorder (JAMA Psychiatry, Aug 2022)
Psilocybin-Assisted Treatment for Alcohol Dependence: a Proof-of-Concept Study (J of Psychopharmacology, Jan 2015)
Ongoing Trials: 8 ongoing/planned trials.
Post-Traumatic Stress Disorder (PTSD): Psilocybin for Trauma Related Disorders Open Label Study (2022)
Smoking Cessation:
Long-Term Follow-Up of Psilocybin-Facilitated Smoking Cessation (American Journal of Drug & Alcohol Abuse, Jan 2017)
Pilot Study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction (J of Psychopharmacology, Sept 2014)
Obsessive Compulsive Disorder (OCD): Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder (2006)
Social Anxiety Disorder: Potential effects on neural activity and connectivity of psilocybin-assisted mindfulness-based intervention for social anxiety disorder: A systematic review (Aug 2022)
Ongoing Trials: Over 60 ongoing or planned trials for various indications.
Increases in divergent thinking (proxy of creativity); greater deliberate and spontaneous problem solving ability after the experience 2021
Increase in Openness and Conscientiousness with decreases in Neuroticism, Introversion, Impulsivity (these traits broadly correlate with mental health)
Personality change in a trial of psilocybin therapy v. escitalopram treatment for depression 2023
Single psilocybin session increased engagement in meditation (depth and frequency of practice)
Meditation retreat plus psilocybin resulted in openness, optimism, and reappraisal of negative emotion
Reductions in self-consciousness (correlate of anxiety, including social anxiety)
Population study on harms and benefits: psychedelics lead to no increase in negative behavioral or mental health outcomes at the population level, and correlate with decreases in PTSD, suicide, panic attacks, anxiety disorders, and psychotic symptoms.
Harm Potential of Magic Mushroom use: A Review
Handbook of Medical Hallucinogens by Charles Grob & Jim Grigsby, “Psilocybin: Potential for Adverse Effects/Safety” p188-192
Review of psilocybin studies by State of Oregon committee of public health experts
Psilocybin-assisted treatment for alcohol dependence
Ayahuasca-Assisted Therapy for Addiction
Treatment-Resistant Depression (severe and persistent depression)
Cancer-related psychiatric distress, more here
Ibogaine treatment outcomes for opioid dependence
Treatment of opioid use disorder with ibogaine
Psychedelics are associated with decreased risk of opioid abuse and dependence.
Summary of research on risks/harms from entheogens and related substances
Effects of psilocybin in healthy humans: a pooled analysis of experimental studies
Human Hallucinogen Research: Guidelines for Safety
SAMHSA National Estimates Of Drug-Related Emergency Department Visits (compiled by the US Govt) - download the Excel file for granular detail
Adverse reactions to psychedelic drugs. A review of the literature
Johns Hopkins' Center for Psychedelic & Consciousness Research
Mass General Hospital Center for the Neuroscience of Psychedelics
NYU Center for Psychedelic Medicine
Mount Sinai Psychedelic Research Center
UW-Madison Master of Science in Pharmaceutical Sciences