The recent review of a new drug application for MDMA-assisted therapy for post-traumatic stress disorder by the United States’ Food and Drug Administration (FDA) highlighted epistemological and methodological challenges for evidence assessments. Similar challenges will also be faced in reviews of other compounds in early- and late-stage development, like psilocybin for depression. The...
Diviner's sage (Salvia divinorum; Lamiaceae) is the source of the powerful hallucinogen salvinorin A (SalA). This neoclerodane diterpenoid is an agonist of the human Κ-opioid receptor with potential medical applications in the treatment of chronic pain, addiction, and post-traumatic stress disorder. Only two steps of the approximately twelve step biosynthetic sequence leading to SalA have been...
Mental health disorders and substance use disorders (SUDs) in particular, contribute greatly to the global burden of disease. Psychedelics, including entactogens and dissociative substances, are currently being explored for the treatment of SUDs, yet with less empirical clinical evidence than for other mental health disorders, such as depression or post-traumatic stress disorder (PTSD). In this...
There is an urgent need to develop better treatments for mental health conditions that affect one in every eight people in the world. To combat this concern, psychedelic drugs have been combined with psychotherapy and studied in clinical trials in the United States and Europe. Psychedelics are hallucinogenic drugs that alter brain activity and facilitate altered states of consciousness. The...
3,4-Methylenedioxymethamphetamine (MDMA) has shown efficacy as a medication adjunct for treating post-traumatic stress disorder (PTSD). However, MDMA is also used in nonmedical contexts that pose risk for cardiovascular and neurologic complications. It is well established that MDMA exerts its effects by stimulating transporter-mediated release of the monoamines 5-hydroxytryptamine (5-HT),...
Title: Use of psilocybin in the treatment of mental disorders: systematic review of clinical trials. Objective: To evaluate the high-impact evidence on the neurobiology, efficacy, safety, and feasibility of using psilocybin in the treatment of mental disorders such as depression, anxiety, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), smoking, and alcoholism
The recent relaxation of psychedelic drug regulations has prompted extensive clinical investigation into their potential use to treat diverse mental health conditions including anxiety, depression, post-traumatic stress, and substance-abuse disorders. Most clinical trials have relied on a small number of known molecules found in nature, such as psilocybin, or long-known synthetic analogs of...
The Food and Drug Administration (FDA) did not accept the application of Lykos Therapeutics for MDMA as a treatment for post‐traumatic stress disorder (PTSD). In a letter dated Aug. 9 and released by Lykos Therapeutics, the for‐profit arm of the Multidisciplinary Association for Psychedelic Studies (MAPS), the company stated that it is disappointed in the FDA response, but that it intends to...
The potent hallucinogen N,N-dimethyltryptamine (DMT) has garnered significant interest in recent years due to its profound effects on consciousness and its therapeutic psychopotential. DMT is an integral (but not exclusive) psychoactive alkaloid in the Amazonian plant-based brew ayahuasca, in which admixture of several β-carboline monoamine oxidase A (MAO-A) inhibitors potentiate the activity...
Psychedelics are psychoactive substances that are known to alter perception, alter mood, and affect numerous cognitive processes. Throughout history, psychedelics were utilized in ceremonies and rituals, and in the 20th century, their utilization in psychiatry began. In the 1960s they became a banned substance and are only recently being revisited for their benefits. The main forms of...