BackgroundPsychedelic-assisted therapy refers to a group of therapeutic practices involving psychedelics taken under therapeutic supervision from physicians, psychologists, and others. It has been hypothesised that psychedelic-assisted therapy may reduce symptoms of anxiety, depression, and existential distress in patients facing life-threatening diseases (e...
Introduction Since the last edition of the Black Book, several innovative agents have been approved or are poised to be approved in the coming year. These include novel antidepressants, the first muscarine agonist for the treatment of schizophrenia, the first psychedelic which may be approved for the treatment of PTSD (Post Traumatic Stress Disorder), and th...
Introduction The use of the psychedelic compound psilocybin in conjunction with psychotherapy has shown promising results in the treatment of psychiatric disorders, though the underlying mechanisms supporting these effects remain unclear. Psilocybin is a Schedule I substance that is dephosphorylated in vivo to form an active metabolite, psilocin. Psilacetin,...
Psilocybe cubensis are a group of mushrooms containing psilocybin with a history of consumption dating back to ancient civilization. Researchers believe the ritual use of psilocybin dates back 3,000 years amongst the indigenous people of Mexico and Central America.1 Psilocybin is responsible for the effects associated with the consumption of “Magic Mushrooms...
Background: Psilocybin has demonstrated promising clinical outcomes for nicotine and alcohol use disorders, yet its potential clinical utility in the treatment of opioid use disorder (OUD) remains unreported in modern literature. This technical report presents methodological considerations and preliminary data from a safety-feasibility trial examining the in...
BACKGROUND: In clinical studies, psychedelics including psilocybin and D-lysergic acid diethylamide (LSD) demonstrate rapid and persistent antidepressant effects. Since the effective treatment with psychedelics is usually provided with psychotherapy, it is debatable whether their prolonged efficacy can be observed in infrahuman species. Preclinical reports o...
Psilocybin is a classical psychedelic which has been utilised for healing purposes for millenia. However, with its classification as a Schedule I substance, research into this compound is scarce with few FDA-approved clinical studies. Despite this, profound findings into its antidepressant effects (largely through its action on 5-HT1a receptors) in mental il...
The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experience to occur while inducing amnesia for the experience. This...
In 1970, the United States Drug Enforcement Administration passed the Controlled Substances Act. This statute classified and banned a variety of drugs including psilocybin, the psychoactive component found in Psilocybe Cubensis (also known as "Magic Mushrooms"). Though psilocybin was known to possess many medical benefits and cause no serious side effects, t...
Background Psilocybin use, along with other psychedelics, has seen an increased interest among professionals in the medical community due to its potential therapeutic benefits for psychiatric disorders, substance use disorders (SUD), and palliative care. While it is certain that more research is necessary as psychedelic-assisted therapy becomes more prevalen...
In 2020, Oregon voters passed the Oregon Psilocybin Services Act (PSA). The PSA allows for the adult use of psilocybin at designated service centers and does not require a medicinal purpose for consumption. While the use of psilocybin becomes legal in Oregon in 2023 under the PSA, psilocybin remains a Schedule I substance under the federal Controlled Substan...
The recent increase in clinical research on the potential therapeutic uses of classic psychedelics has prompted the need to revisit the assessment of the abuse potential of these drugs. The term "classic psychedelic" is used in this manuscript to describe serotonergic 5-HT2A agonists that alter perception, cognition, and mood (i.e., psychedelic effects) and ...
Microdosing-the intermittent ingestion of minute, sub-hallucinogenic amounts of psychedelic substances, repeatedly and over time-has become a widespread, albeit largely understudied, phenomenon. Regulations around using psychedelics at any dose-micro, mini, macro, or mega-pose all sorts of difficulties for those who wish to systematically study the effects o...
Post-traumatic stress disorder (PTSD) is a devastating psychiatric disorder afflicting millions of people around the world. Characterized by severe anxiety, intrusive thoughts, pervasive nightmares, an assortment of somatic symptoms, associations with severe long-term health problems, and an elevated risk of suicide, as much as 40-70% of patients suffer from...
Psychedelic-assisted psychotherapy holds great promise in the treatment of mental health disorders. Research into 5-hydroxytryptamine 2A receptor (5-HT2AR) agonist psychedelic compounds has increased dramatically over the past two decades. In humans, these compounds produce drastic effects on consciousness, and their therapeutic potential relates to changes ...
Introduction Psilocybin is a psychedelic drug found in mushrooms, often referred to as magic mushrooms due to its visual and auditory hallucinations effects upon ingestion. It is a Schedule I drug per DEA, and the FDA has not approved psilocybin for medicinal purposes. However, recent studies have shown promising therapeutic use to treat depression. Objectiv...
New medicines containing classic hallucinogenic and entactogenic psychedelic substance are under development for various psychiatric and neurological disorders. Many of these, including psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxymethamphetamine (MDMA) are Schedule I controlled substances of the United States Controlled Substances Act...
BackgroundEvidence points to an incongruence between international drug policy and expert opinion about safety, abuse potential, and therapeutic potential of specific drugs. However, no prior studies have directly explored psychiatrists' attitudes about the current drug schedule. Therefore, we examined whether American psychiatrists' perceptions of four psyc...
The Food and Drug Administration (FDA) granted breakthrough therapy status to 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) in 2017 due to preliminary evidence supporting its efficacy and safety in treating post-traumatic stress disorder (PTSD). A series of six phase-II clinical trials studying MDMA-AT for treatment-resistant PTSD found that...
Introduction Psilocybin is a psychedelic drug found in mushrooms, often referred to as magic mushrooms due to its visual and auditory hallucinations effects upon ingestion. It is a Schedule I drug per DEA, and the FDA has not approved psilocybin for medicinal purposes. However, recent studies have shown promising therapeutic use to treat depression. Objectiv...
