As federal regulators consider the future role of psychedelic therapies, behavioral health leaders are urging early planning around workforce development, clinical training and equitable access. The U.S. Food and Drug Administration (FDA) on Sept. 14 convened a four‐hour public hearing with federal partners to examine the potential therapeutic use of psychedelic drugs.
Given the growing interest in psychedelic‐assisted therapies, questions remain about how such services perform outside controlled clinical trials. A new JAMA Network Open study offers an early look at the risks and benefits of Oregon's state‐regulated psilocybin program, which researchers describe as the first study of its kind in the nation.
A team of researchers in Connecticut is advancing inquiry into the potential of psychedelics in mental health treatment through an ongoing study involving patients with complex conditions. A psilocybin trial that initially recruited military veterans, first responders and health care workers has shown promising results and is being expanded to include a broader population.
The U.S. departments of Health and Human Services (HHS) and Veterans Affairs (VA) have entered into a five‐year agreement to coordinate research, clinical development and future implementation of rapid‐acting psychiatric treatments, including psychedelic‐based therapies, for veterans with serious mental health conditions, an HHS news release stated. Under the agreement, the agencies will expand...
For many patients with major depressive disorder, reaching remission — not just partial response — can significantly alter the course of illness, lowering the risk of relapse and improving day‐to‐day functioning. Yet that goal remains elusive for those with treatment‐resistant depression (TRD), where repeated medication failures, comorbid conditions, and lingering symptoms complicate care. Data...
A single dose of psilocybin may provide rapid relief for people with major depressive disorder (MDD), with benefits emerging within days and lasting for several weeks, according to a randomized clinical trial published May 15 in JAMA Network Open . Researchers of the study, “Short‐Term and Late‐Term Effects of Psilocybin on Symptoms in Major Depression: A Randomized Clinical Trial,” found that...
The U.S. Department of Veterans Affairs (VA) has launched a clinical trial to evaluate the safety and efficacy of MDMA‐assisted therapy for treating severe mental health disorders, including posttraumatic stress disorder (PTSD) and alcohol use disorder, a news release announced May 26.
New findings published this month in The American Journal of Psychiatry (AJP) on the use of ketamine followed by ultra‐low‐dose buprenorphine to sustain reductions in suicidal ideation are drawing attention from suicide prevention experts, who say the approach may help address a long‐standing gap in treatment during high‐risk periods following a crisis (see related story, p. 3).
A new executive order from the White House could jump‐start additional research and new approvals of psychedelic drugs for the treatment of serious mental illness (SMI). Among its provisions, the April 18 order directs federal agencies to expedite reviews of products that have successfully completed Phase 3 trials, so that they can be more rapidly rescheduled from their current Schedule I (no...
Support for the legal use of psilocybin mushrooms (23%) is much lower than it is for cannabis (65%), according to a new RAND research report, released Feb. 24. For LSD and 3,4‐methylenedioxymethamphetamine (MDMA)–assisted therapy, support for legal use is closer to 10%.
Microdosing — once a niche practice whispered about in online forums and tech circles — has firmly entered the mainstream. A new RAND survey suggests that millions of U.S. adults are now taking sub‐perceptual amounts of psychedelics such as psilocybin, LSD and MDMA, often with goals that differ sharply from those associated with traditional, full‐dose use.
In a historic move toward transparency, the U.S. Food and Drug Administration (FDA) on Sept. 4 publicly released its Complete Response Letter (CRL) rejecting the approval of midomafetamine (MDMA)‐assisted therapy for post‐traumatic stress disorder (PTSD). The letter, sent to Lykos Therapeutics in August 2024, outlines concerns about treatment durability, study design and prior MDMA use among...
Results of new psychedelic research aimed at patients with severe treatment resistant depression (TRD) found significant decreases in their depressive symptoms. Researchers of the open‐label study also found significant safety and efficacy of synthetic psilocybin in TRD patients.
In a closely watched decision involving the use of psychedelic treatment and therapy to treat post‐traumatic stress disorder (PTSD), the U.S. Food and Drug Administration (FDA) on Aug. 9 declined to approve the use of midomafetamine (MDMA)‐assisted therapy for the disorder. The federal agency issued a Complete Response Letter (CRL) for MDMA‐assisted therapy to its drug maker, Lykos Therapeutics.
A recent decision by the U.S. Food and Drug Administration's (FDA) advisory committee to reject psychedelic treatment and therapy to treat post‐traumatic stress disorder (PTSD), citing that the available evidence of midomafetamine, better known as MDMA, fails to show that the drug is effective, has been met with mixed reaction by a member of the field and an advocacy organization committed to...
A New York‐based organization, considered a global leader in professional education and training for psychedelic therapy research, is collaborating with a biotechnology company to develop an FDA‐approved botanical psilocybin pharmaceutical candidate to support an upcoming randomized clinical trial.
A clinical‐stage biopharmaceutical company that officials said is committed to revolutionizing mental health care by developing new and innovative next‐generation psychedelic‐based treatment options, announced last week that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for an adjunctive psychedelic‐based therapy for the treatment of major...
In response to the psychological trauma inflicted by the ongoing conflict in Ukraine, Fluence, a leader in comprehensive, evidence‐based training in psychedelic therapy announced last week a collaboration with the Ukrainian Psychedelic Research Association (UPRA) and the U.S. nonprofit Health Ukraine Trauma (HUT), to provide free training in psychedelic therapy to Ukrainian psychologists and...
Observing that ketamine infusion therapy is increasingly being used for such mental health conditions as major depressive disorder, bipolar disorder, treatment‐resistant depression, and post‐traumatic stress disorder, two national nursing associations have released a joint statement indicating that patients with psychiatric disorders may benefit from the use of ketamine infusion therapy.
The third part of a new study assessing MDMA‐assisted therapy, a psychedelic drug also known as Ecstasy, has revealed improvement in diverse individuals suffering with severe post‐traumatic stress disorder (PTSD). The study, “MDMA‐assisted therapy for moderate to severe PTSD: a randomized, placebo‐controlled phase 3 trial,” published Sept. 14 in Nature Medicine.
This month's announcement of up to $285 million in private placement financing for a leading developer of psychedelic drug therapies signals an important validation of this drug sector's role in mental health treatment, the biotechnology company's CEO told MHW last week.
Mindfulness, considered a robust coping mechanism, can serve as a potential buffer to the negative consequences of impulsivity associated with suicide ideation among young Black adults, according to researchers of a study published in Mindfulness. Researchers said the current research is the first to examine mindfulness in addressing suicidal ideation among the younger Black population.
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 psilocybin and MDMA (ecstasy).
A newly published study offers support for another viable treatment option for patients with an anxiety disorder who hesitate to take medication or aren't a good candidate for psychotherapy. The study found that eight weeks of a structured mindfulness‐based intervention was noninferior to eight weeks of anti‐depressant treatment in reducing anxiety symptoms.
Acknowledging the barrage of research, media attention and capital investment focused on psychedelic compounds and the race to reach U.S. Food and Drug Administration (FDA) approval for such currently illegal drugs as psilocybin, nearly two dozen experts have weighed in on a new report that, among other things, calls attention to the critical role they said therapists play in the...