Psilocin is the active metabolite of psilocybin a natural material found in several types of fungi. The bioavailability of psilocybin, the prodrug of psilocin, has been reported to be over 60%. However, pharmacokinetics and bioavailability of psilocin mucate has not been reported. This Phase I "First in Man" study of psilocin mucate is designed to determine ...
Purpose of reviewThis review discusses the current and projected landscape of psychedelic-assisted therapy (PAT), with a focus on clinical, legal, and implementation considerations in Department of Defense (DoD) and Department of Veterans Affairs (VA) healthcare systems.Recent findings3,4-Methylenedioxymethamphetamine (MDMA)- and psilocybin-assisted therapy ...
Background: Psilocybin and psychedelic-assisted therapy (PAT) have gained renewed interest due to recent findings that PAT can enhance therapeutic outcomes. In 2019, the U.S. Food & Drug Administration (FDA) approved breakthrough therapy status to psilocybin for the treatment of depression, but PAT has yet to be approved as a therapeutic treatment for mental...
Back to table of contents Previous article Next article Clinical & ResearchFull AccessAustralia Legalizes Psychedelics for Use in Depression, PTSD TherapyNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:15 Aug 2023https://doi.org/10.1176/appi.pn.2023.09.9.20AbstractThe country is the first to make psilocybin and MDMA available ...
Back to table of contents Previous article Next article Med CheckFull AccessMed Check: FDA, Anti-Amyloid Beta Vaccine, Clinical Trials of Psychedelics, and LumryzTerri D’ArrigoTerri D’ArrigoSearch for more papers by this authorPublished Online:27 Jul 2023https://doi.org/10.1176/appi.pn.2023.08.8.3FDA Expedites Review of Anti-Amyloid Beta Vaccine for Alzheime...
Observing that designing clinical studies to evaluate the safety and effectiveness of psychedelic substances presents a number of unique challenges that require careful consideration to the industry, the U.S. Food and Drug Administration (FDA) last month issued, for the first time, draft guidance for conducting clinical trials with psychedelic drugs such as ...
Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Currently, there are only two approved medications in the United...
Abstract Psychoactive substances such as psilocybin and 3,4-methylenedioxy-methamphetamine (MDMA) are currently being investigated for a variety of psychiatric indications including major depressive disorder and post-traumatic stress disorder. It is critical that clinicians working in the mental health field understand the regulatory framework that balances ...
This Special Issue of Neuropharmacology on psychedelics provides a timely and comprehensive update on progress following the previous Neuropharmacology Special Issue "Psychedelics: New Doors, Altered Perceptions". Remarkable advances have been made in basic and clinical research on psychedelics in the five years since 2018. It is partly based on the seminar ...
Post-Traumatic Stress Disorder (PTSD) is a mental health condition that occurs as a result of a traumatic experience. Symptoms include feeling anxious, flashbacks, nightmares and difficulty sleeping. Several studies indicate that psilocybin-assisted psychotherapy (PaP) may be an effective treatment for a number of mental health conditions. This has led to Pa...
Psychedelic substances are under investigation in several drug development programs. Controlled clinical trials are providing evidence for safe and effective use of psychedelic therapies for treating mental health conditions. With the anticipated FDA approval of MDMA-assisted therapy for posttraumatic stress disorder in 2023 and psilocybin therapy for depres...
Major depressive disorder presents a substantial global health burden, and at least 30-40% of patients exhibit treatment resistance to antidepressants. Ketamine, an NMDA receptor antagonist, is used as an anesthetic agent. In 2019, the U.S. Food and Drug Administration (FDA) approved esketamine (the S-enantiomer of ketamine) as a therapeutic agent for treatm...
The clinical evaluation of hallucinogens and other small molecules, conventionally termed psychedelics, has seen a dramatic increase in the past 5 years. Several key clinical trials recently demonstrated the potential efficacy of these compounds in treating a variety of mental health conditions including depression, anxiety, and substance use disorders. Conc...
Back to table of contents Previous article Next article Clinical & ResearchFull AccessPsychedelic Renaissance: Clinical Health Justice, Patient Safety, and Equity Need to Be Put FirstJacques Ambrose, M.D., M.P.H., Jeffrey Zabinski, M.D., M.S.W.Jacques AmbroseSearch for more papers by this author, M.D., M.P.H., Jeffrey ZabinskiSearch for more papers by this a...
Back to table of contents Previous article Next article Government & LegalFull AccessPsychedelics Legislation Gains MomentumTerri D'ArrigoTerri D'ArrigoSearch for more papers by this authorPublished Online:16 Feb 2023https://doi.org/10.1176/appi.pn.2023.03.3.4AbstractBills that would decriminalize the use of psychedelics are popping up faster than magic mush...
No single effective therapy for alcohol abuse has been found, despite it being a serious sociological and economic problem for hundreds of years. It seems difficult to find a single drug as a panacea for the alcohol problem due to the complexity of the pathophysiology of alcohol dependence. The purpose of this narrative review is to review existing and poten...
Objective: Psychedelic drug therapy is banned in all countries of the world except Australia, where the government regulatory watchdog, the Therapeutic Goods Administration, is planning to allow approved psychiatrists, as of July 1, 2023, to prescribe psilocybin to treat depression and MDMA to treat post-traumatic stress disorder, a move precipitated by the ...
Psychedelics were used in the treatment of psychiatric conditions prior to their prohibition in the late 1960s. In the past three decades, there is a revived research interest in the therapeutic potential of psychedelic drugs with expected FDA approvals for treatment of various conditions. Given the exponential scientific growth of this field, we sought to c...
Recent clinical trials of psychedelic drugs aim to treat a range of psychiatric conditions in adults. MDMA and psilocybin administered with psychotherapy have received FDA designation as "breakthrough therapies" for post-traumatic stress disorder (PTSD) and treatment-resistant depression (TRD) respectively. Given the potential benefit for minors burdened wit...
Cannabis use disorder (CUD) is prevalent in ~2-5% of adults in the United States and is anticipated to increase as restrictions to cannabis decrease and tetrahydrocannabinol (THC) content in cannabis products increase. No FDA-approved medications for CUD are currently available, despite trials of dozens of re-purposed and novel drugs. Psychedelics have garne...
