Post-traumatic stress disorder (PTSD), characterized by abnormally persistent and distressing memories, is a chronic debilitating condition in need of new treatment options. Current treatment guidelines recommend psychotherapy as first line management with only two drugs, sertraline and paroxetine, approved by U.S. Food and Drug Administration (FDA) for trea...
Abstract The ‘‘psychedelic renaissance’’ is generating new evidence for psychedelics’ potential to treat numerous mental and substance use disorders. In particular, the United States Food and Drug Administration is poised to approve psychedelic drugs 3,4 methylenedioxymethamphetamine (MDMA) and psilocybin for the use in psychedelic-assisted therapy (PAT). Th...
Rationale & objectives ± 3,4-Methylenedioxymethamphetamine (MDMA) and psilocybin are currently moving through the US Food and Drug Administration's phased drug development process for psychiatric treatment indications: posttraumatic stress disorder and depression, respectively. The current standard of care for these disorders involves treatment with psychiat...
Psilocybin, a serotonergic agonist, was granted a "breakthrough therapy" status by the Food and Drug Administration for clinical trials involving major depressive disorder and treatment-resistant depression. The direct phosphorylation of psilocin to psilocybin that uses a fast crystallization associated with a kinetically controlled process resulted in a sma...
A confluence of factors has renewed interest in the scientific understanding and translational potential of psychedelic drugs such as lysergic acid diethylamide (LSD), mescaline, and psilocybin: the desire for additional approaches to mental health care, incremental progress in basic and clinical research, and the reconsideration and relaxation of existing d...
Back to table of contents Previous article Next article ViewpointsFull AccessPsychedelic Drugs for Mental Disorders and Human Potential: Placebo or PanaceaDavid Hellerstein, M.D., Kevin Sabet, Ph.D., Jeffrey A. Lieberman, M.D.David HellersteinSearch for more papers by this author, M.D., Kevin SabetSearch for more papers by this author, Ph.D., Jeffrey A. Lieb...
The studies of psychedelics, especially psychedelic tryptamines like psilocybin, are rapidly gaining interest in neuroscience research. Much of this interest stems from recent clinical studies demonstrating that they have a unique ability to improve the debilitating symptoms of major depressive disorder (MDD) long-term after only a single treatment. Indeed, ...
As both 3,4-methylenedioxymethamphetamine (MDMA)- and psilocybin-assisted psychedelic psychotherapy near U.S. Food and Drug Administration (FDA) approval and gain acceptance as efficacious clinical approaches, concerns have been raised about the likelihood of sexual violation of a client and other relational boundary transgressions. In the current study, 23 ...
Back to table of contents Previous article Next article Clinical & ResearchFull AccessPsychedelic Therapy Hits Another Milestone, But Caution UrgedNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:22 Jul 2021https://doi.org/10.1176/appi.pn.2021.7.14AbstractPositive findings from a phase 3 trial may have brought MDMA-assisted the...
A psychedelic drug is one that “produces thought, mood and perceptual changes otherwise rarely experienced except in dreams, contemplative and religious exaltation, flashes of vivid involuntary memory, and acute psychosis”1. It does so “without causing physical addiction, craving, major physiological disturbances, delirium, disorientation or amnesia”1. The “...
This review examines the role of trauma in psychiatric morbidity and analogous psychoneurobiological changes. Trauma is a necessary criterion for Post-Traumatic Stress Disorder (PTSD), however, trauma history is highly correlated with a variety of psychiatric conditions. Some evidence suggests that Major Depressive Disorder (MDD) is the most common psychiatr...
Back to table of contents Previous article Next article ViewpointsFull AccessThe Return of Psychedelics: Still Time to Prevent TragedyStanley N. Caroff, M.D.Stanley N. Caroff, M.D.Published Online:31 Mar 2021https://doi.org/10.1176/appi.pn.2021.4.8AbstractRecently, a movement reviving psychedelic drugs has emerged among physicians, echoed by activists like M...
Back to table of contents Previous article Next article APA & MeetingsFull AccessSession on Psychedelics Sure to Be EnlighteningNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:2 Mar 2021https://doi.org/10.1176/appi.pn.2021.3.14AbstractLeaders in psychedelic research will discuss the therapeutic potential of psychedelic compoun...
BackgroundPsychedelic compounds such as lysergic acid diethylamide (LSD), psilocybin, and 3,4-Methylenedioxymethamphetamine (MDMA) share a long and complex history with psychiatry. A half century ago, psychedelics were widely employed by psychiatrists in investigational and clinical settings, with studies demonstrating promising findings for their use in the...
Mounting evidence suggests safety and efficacy of psychedelic compounds as potential novel therapeutics in psychiatry. Ketamine has been approved by the Food and Drug Administration in a new class of antidepressants, and 3,4-methylenedioxymethamphetamine (MDMA) is undergoing phase III clinical trials for post-traumatic stress disorder. Psilocybin and lysergi...
The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer. Secondary outcome measures will look at the ef...
Back to table of contents Previous article Next article ViewpointsFull AccessWait for the Science Before Widespread Use of PsilocybinNicole Harrington Cirino, M.D.Nicole Harrington Cirino, M.D.Published Online:28 Sep 2020https://doi.org/10.1176/appi.pn.2020.10a32AbstractThe momentum behind psilocybin as the next big "breakthrough" in treating psychiatric dis...
There are few medications with demonstrated efficacy for the treatment of posttraumatic stress disorder (PTSD). Treatment guidelines have unequivocally designated psychotherapy as a first line treatment for PTSD. Yet, even after psychotherapy, PTSD often remains a chronic illness, with high rates of psychiatric and medical comorbidity. Meanwhile, the search ...
Although research findings to date do not support the use of psychedelic compounds in the treatment of psychiatric disorders, the existing body of research justifies continued investigation, a literature review concludes. The review found the most significant evidence supporting use of psilocybin and 3,4-methylenedioxymethamphetamine (MDMA). Both of these dr...
Back to table of contents Previous article Next article Clinical & ResearchFull AccessPsychedelics for Psychiatric Disorders: More Research NeededNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:13 Apr 2020https://doi.org/10.1176/appi.pn.2020.4a14AbstractAPA’s Work Group on Biomarkers and Novel Treatments suggests that psychede...
