A seismic shift in how we discuss mental health has occurred over the past few years. A willingness to engage in the topic beyond mere lip service at home, in our communities, and in our places of work is a testament to the profound progress that has been made in reducing the stigma associated with these conditions of Health and Human Services create a federal inter-agency task force to address issues of psychedelic use, therapy, and health care integration. Proposed pieces of legislation have been introduced to allow for psychedelic use under the federal Right to Try Act, and to amend the Controlled Substances Act to grant the U.S. Drug Enforcement Administration the ability to transfer Schedule I substances into Schedule II provided such substances have received either FDA Breakthrough Therapy designation or authorization for use in FDA’s expanded access program.
Finally, a bipartisan Congressional caucus entitled Psychedelics Advancing Clinical Treatments (“PACT”) was formed this past November to explore psychedelic research related to mental health conditions.
Medicinal psychedelics are coming to mainstream health care in the very near future. But the treatment protocols and clinical settings in which psychedelic care is delivered will be very different from any existing model in our health care system. Medical professionals and health care entities seeking to operate in this new medicinal psychedelics space should consider engaging legal counsel who possess not only a strong comprehension of the law, but also an in-depth understanding of the science behind these drugs and their medical applications. Kyle W. Mack, J.D., Pharm.D., is special counsel at Phillips Lytle, co-leader of the firm’s Psychedelics & Mental Health Therapies Practice Team and a member of the firm’s Life Sciences & Health Effects Practice Team. He can be reached at (716) 847-7068 or kmack@phillipslytle.com. in a relatively short amount of time. Equally as profound are efforts by clinicians, researchers, and state and federal legislators to find and implement new treatment options for mental health conditions. These efforts have been focused on an area of pharmacology that one might think strange or even absurd at first blush: psychedelics. Psilocybin (“magic mushrooms”), MDMA (“ecstasy,” “molly”), LSD (“acid”), and dimethyltryptamine (“DMT”) are all being researched as medications to treat a wide variety of mental health and substance use disorders. Why? Because clinical research has shown – and is continuing to show – that these compounds may have superior efficacy compared to existing FDA approved medications when combined with psychotherapy. In August 2017, the FDA granted Breakthrough Therapy designation to MDMA for the treatment of posttraumatic stress disorder (PTSD). In 2018 and 2019, it granted Breakthrough Therapy designations to psilocybin for treatment-resistant depression and major depressive disorder, respectively. Breakthrough Therapy designation is a process designed to speed up the development and review of medications intended for the treatment of serious conditions. It is granted on the basis of preliminary clinical evidence indicating that the medication under investigation may have potential for superiority over approved therapies on at least one clinically significant endpoint. FDA approval of MDMA for PTSD is expected in 2024, with approvals for psilocybin to follow.
While drug sponsors pursue the FDA approval route, several states have taken initiatives to create their own state-regulated frameworks to bring psychedelic compounds to their residents in controlled settings. Oregon was the first to pass legislation providing for psilocybin treatment centers. Connecticut and Colorado have since passed their own measures. New York has two proposed Assembly bills (A8569a, A7928) and one proposed Senate bill (S3520) that would establish regulated systems for the medical administration of psychedelics for mental health conditions. A8569a was introduced by Buffalo native, Assemblyman Patrick Burke. These state initiatives across the country are occurring at a time when psychedelics are still classified as illegal narcotics under the federal Controlled Substances Act. But federal bipartisan support for the use of these compounds as medications appears strong. In the past year, members of Congress have requested that the U.S. Department
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Authors
By Kyle W. Mack, J.D., Pharm.D. Phillips Lytle LLP
LOS ANGELES, May 17, 2024 (GLOBE NEWSWIRE) — PsychedelicNewsWire (“PNW”), a specialized communications platform for the psychedelics sector and one of the 60+ brands powered by IBN (“InvestorBrandNetwork”), is pleased to announce that it will be the Official Media Sponsor for the 4th Annual Psychedelic Therapeutics and Drug Development Conference (“the conference”), an industry flagship event dedicated to research and development of psychedelics in the healthcare space hosted by Arrowhead SciTech Conferences & Events (“Arrowhead”). The event will be held at the iconic Revere Hotel Boston Common, 200 Stuart Street, Boston, MA 02116 on 23-24 May 2024
While psychedelics have shown promise in treating certain mental health conditions, a recent study suggests they may pose risks for individuals with personality disorders. The findings underscore the importance of careful screening and personalized approaches in psychedelic-assisted therapy.
Navigating the Psychedelic Landscape: Potential Risks for Individuals with Personality Disorders
Psychedelics, including substances like psilocybin and LSD, have gained significant traction in recent years for their potential therapeutic benefits in treating mental health conditions such as depression, anxiety, and PTSD. However, a recent publication in the Journal of Psychopharmacology has raised concerns about the suitability of these substances for individuals with personality disorders.
The study surveyed individuals who had used psychedelics and who were also diagnosed with personality disorders. A considerable number of respondents reported negative and persistent psychological impacts following their psychedelic experiences. Notably, these included heightened anxiety, paranoia, mood instability, and an exacerbation of existing personality disorder symptoms.
Researchers suggest that the vulnerability of individuals with personality disorders to the adverse effects of psychedelics may stem from pre-existing challenges in emotional regulation, self-identity, and interpersonal relationships. The profound and introspective nature of psychedelic experiences can intensify these issues, potentially leading to psychological distress and symptom aggravation.
This research highlights the critical need for thorough screening and assessment in the context of psychedelic-assisted therapy. It suggests that individuals with personality disorders might require tailored therapeutic approaches and robust support systems to navigate potential risks and to secure safe and positive outcomes.
Why It Matters
The burgeoning interest in psychedelic therapy underscores the necessity to discern both the potential benefits and risks across different demographic groups. This study contributes valuable insights, particularly for clinicians and researchers, stressing the importance of personalized treatment plans and the cautious consideration of individual vulnerabilities when administering psychedelic-assisted therapy.
Potential Implications
The findings from this study emphasize the need for ethical and responsible practices within the field of psychedelic-assisted therapy. There is a pressing requirement for the development of detailed screening protocols that can identify individuals who may be more susceptible to the adverse effects of psychedelics. Furthermore, crafting specialized therapeutic strategies that cater specifically to the needs of individuals with personality disorders is essential for ensuring their safety and overall well-being during and after undergoing psychedelic experiences.
The Bigger Picture
The debate surrounding the therapeutic use of psychedelics is complex, with various factors influencing the suitability of these treatments for different individuals. While there are promising results in general populations, the nuanced needs and potential vulnerabilities of those with personality disorders require careful consideration to prevent harm and maximize therapeutic outcomes. This necessitates ongoing research, improved clinical protocols, and a commitment to patient-centered care in the burgeoning field of psychedelic medicine.
Recent research suggests that psychedelics and traditional antidepressants, while both potentially effective in treating depression, work through distinct mechanisms. Understanding these differences could lead to more personalized and effective treatment approaches.Psychedelics vs. Antidepressants: What are the key differences?
Unlocking the Mysteries of Depression Treatment: Psychedelics vs. Antidepressants
The quest for effective depression treatments continues to be a significant focus in mental health research. Traditional antidepressants, like selective serotonin reuptake inhibitors (SSRIs), have been a mainstay in treatment, prescribed widely despite varying efficacy among individuals and often accompanying unwanted side effects. In contrast, psychedelics have recently garnered attention for their rapid and enduring antidepressant effects observed in clinical trials.
A recent study has delved into the distinct mechanisms of action of SSRIs and psychedelics, illuminating how they uniquely influence the brain and potentially alleviate symptoms of depression. SSRIs primarily increase serotonin levels in the brain, which is believed to enhance mood and diminish depressive symptoms. However, this process can require several weeks to manifest noticeable effects, and not all patients respond favorably to SSRIs.
Conversely, psychedelics such as psilocybin, found in “magic mushrooms,” operate through a different mechanism. Research indicates that psilocybin’s antidepressant effects are not directly due to elevated serotonin levels. Instead, psilocybin is thought to promote neuroplasticity, the brain’s capacity to reorganize and form new neuronal connections. This heightened neuroplasticity may facilitate more adaptable thought patterns and an improved ability to process emotions, contributing to the rapid and sustained antidepressant effects seen in clinical trials.
Moreover, the study examined the role of the 5-HT2A serotonin receptor, a primary target for both SSRIs and psychedelics. While SSRIs inhibit this receptor’s activity, psychedelics activate it. Intriguingly, blocking the 5-HT2A receptor did not reduce psilocybin’s antidepressant effects, suggesting that its therapeutic benefits originate from other pathways.
Psychedelics vs. Antidepressants: Why It Matters?
Understanding the distinct mechanisms by which psychedelics and antidepressants affect the brain is crucial for the development of more personalized and effective treatment strategies for depression. This knowledge could lead to enhanced patient selection for specific treatments, reducing trial and error while optimizing outcomes. Furthermore, exploring the unique properties of psychedelics may pave the way for novel antidepressant medications that are quicker acting and have fewer side effects.
Potential Implications
This research could catalyze a shift in depression treatment paradigms, moving from a one-size-fits-all approach to more targeted therapies. By pinpointing the specific mechanisms that underlie different antidepressant interventions, clinicians can customize treatment plans based on individual patient profiles and needs. This personalized approach could improve treatment success rates and enhance the quality of life for individuals battling depression.
What Next?
While the study of psychedelics for therapeutic purposes is still in its nascent stages, the initial findings are promising and suggest that psychedelics may offer a valuable addition to the arsenal of tools for combating depression and other mental health conditions.