Integration Communications’ Post

While the FDA advisory committee identified many challenges associated with developing MDMA as a treatment for PTSD, “there will be other chances” for developing psychedelic-inspired medicines according to IPN Director David E. Olson. The advisory committee’s discussion reinforces the need for rigor in the design of clinical trials using psychedelics and highlights the importance of identifying next-generation compounds that solve some of the issues raised by the committee. While the path forward for MDMA treatment may be complex, the potential benefits for mental health are profound. Read this Science Magazine article for a more thorough dive into the FDA advisory committee’s discussion.   #psychedelictherapy 

…And you’re going to #want my #book if you want to know #heal i tell it all through my #healing journey people… A) How to #heal (if you need #mdma or any type of #psychedelic HOW LEGALIZATIONIS COMING AND HOW AND WHY I KNOW WHEN) B) Ways to become #successful I’ve learned how easy #life is once you #heal yourself + I’m teaching you how to become the #GOAT All in my #newbook #book #books #dm #follow #msg me I can #signyouup and get you a copy on my #list today!

A historic milestone in the field of psychedelic medicine this week! 👏👏👏 MAPS Public Benefit Corporation (MAPS PBC) has submitted a New Drug Application (NDA) to the FDA seeking approval of MDMA used in combination with psychological intervention (psychotherapy, talk therapy, and other integrative services) for treating post-traumatic stress disorder (PTSD). “The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration, and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” said Amy Emerson, chief executive officer, MAPS PBC. “If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.” MAPS recently completed two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) and found the treatment highly effective for both moderate and severe PTSD. Importantly, no serious adverse events occurred in the MDMA group across trials. 💫 “With Breakthrough Therapy designation given to MDMA in 2017, MAPS PBC has requested the FDA grant Priority Review of the NDA. The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively). If approved by the FDA, the U.S. Drug Enforcement Administration (“DEA”) would be required to reschedule MDMA making it available for prescription medical use.” Read the full press release here 🔗https://lnkd.in/e5puTRUv #psychedelicassistedtherapy #psychedelicmedicine #mentalhealth

https://lnkd.in/gYzAVktW Saw this inbox. Sparked curiosity. Wondering about guidelines. None are yet agreed. None are yet deemed robust by relevant health practice professions, or by regulatory authorities. Here is a quandary that comes to inquiring minds, us professionals who strive ethically to support our clients in line with best and safest avenues of awareness-focused education, referral, and care-system integration: Considering psychedelic treatments, of any sort; as alternatives to clients using no substance, or using prescribed remedies, or instead relying on illicit 'self-medicating' (or choosing MAID): Question #1: What is the 'right touch' guideline, for professionals accurately estimating and documenting the 'tipping point', that clinically rationalizes a referral for alleviating anxiety and related conditions, using psychedelics? Are psychedelics 'instead of', 'in addition to' (adjunct), or 'after exhausting' the efforts of psychotherapy and counselling? Question #2: What is the guideline for regulated health professionals informing (indirectly endorsing) a client's interest in this option? Question #3: What are the 'right touch' criteria to safeguard both client rights and our ethical obligations (e.g., duty of care, due diligence to safe and effective services)? Question #4: When is pharmacotherapy using psychedelics appropriate as adjunct, or alternative, to psychotherapeutic interventions by a regulated health professional? Question #5: Who is responsible for communicating the trustworthy (reliable, valid, robust, rigorous) research and engaging cross-sector discussions of guidelines that make sense to client safety, choice, effectiveness, and relief? #clinicalevaluation #patientsafety #pharmacotherapy #psychotherapy #medicalethics #healthethics #socialwork #psychedelics #hypnotherapy #virtualreality

A Breakthrough in Treating Anxiety: Single Dose of #LSD-Based Medicine Shows Remarkable Promise A groundbreaking study has revealed that a single dose of an #LSD-based medication could provide rapid and lasting relief for generalized #anxiety disorder (GAD), offering hope for novel treatments amidst the ongoing mental health crisis. At First Tracks, we are committed to advancing mental health care and sharing the latest research in treatment. We are excited to report the promising results from a phase 2B study of MM120 (lysergide d-tartrate), an investigational LSD-based medicine developed by MindMed. 🔹Rapid and Durable Response: A single oral dose of MM120 100 µg demonstrated rapid improvement in GAD, with 65% of patients experiencing a 50% reduction in anxiety and 48% achieving remission at 12 weeks. 🔹Broader Impact: Beyond anxiety, MM120 also led to significant improvements in depressive symptoms, indicating its potential for comprehensive mental health support. 🔹 Safety and Tolerability: The treatment was well-tolerated, with most adverse events being mild to moderate and transient, consistent with the expected effects. 🔹 Next Steps: With these encouraging results, a phase 3 study is on the horizon, moving us closer to new, effective treatments for GAD. We love following these groundbreaking advancements in mental health treatment and remain committed to integrating innovative, evidence-based solutions into #healthplans as they receive federal approval. Together, we can work towards a future where comprehensive, cutting-edge mental health care is accessible to all. https://lnkd.in/etZyQaXW #MentalHealthInnovation #EvidenceBasedTreatment #GADTreatment #LSDResearch #FirstTracks #MindMed #MentalHealthAwareness

Today, we celebrate a momentous milestone in the world of psychedelic research. The Segal Trials’ Center for Psychedelic Research is thrilled to share that the (Multidisciplinary Association for Psychedelic Studies (MAPS) has officially submitted New Drug Approval for MDMA as a treatment for Post-Traumatic Stress Disorder (PTSD) to the FDA! This historic achievement marks a significant step forward in harnessing the potential of psychedelics to alleviate the suffering of those affected by PTSD. The rigorous research conducted by MAPS has paved the way for a groundbreaking therapeutic option that could change countless lives. At Segal Trials, we are proud to be a part of this transformative journey. Our commitment to advancing the science of psychedelic medicine is unwavering, and we look forward to seeing the positive impact that MDMA-assisted therapy could have on individuals struggling with PTSD. Let's continue to support and champion the incredible work being done in the field of psychedelic research. Together, we can make a difference and offer hope to those in need. https://lnkd.in/e5puTRUv #PsychedelicResearch #MDMA #PTSD #MAPS #FDAApproval #SegalTrials #MentalHealthMatters

This is a Virtual Event for PsychU members in Florida and Georgia. In this presentation, the objectives are to: 1) Understand the impact of mood episode recurrence in bipolar I disorder on patient functioning and clinical outcomes 2) Discuss risk factors for mood episode recurrence, including nonadherence, in patients with bipolar I disorder 3) Review management strategies, including long-acting injectable antipsychotics (LAIs), to optimize patient outcomes in bipolar I disorder #bipolardisorder #bipolarawareness #bipolar #patientoutcomes #antipsychotics

The CRL (Complete Response Letter) was handed down by the FDA today, and for many it feels like a defeat. I am going to counter that position. Not because I think it’s my job as a Founder of a nonprofit dedicated to this movement, or because I simply have time invested in a cause and can’t let go, or because I just like to instigate rebellion (okay, last one might be a little true), but what the CRL shows me is the promise of CLARITY. The CRL affirms the FDA’s belief in MDMA-assisted therapy as a treatment for PTSD. This in itself is an incredible accomplishment that was made possible by the investment of time, energy, and heart by scientists, advocates, and participants. This work will continue, but we can all take a moment to celebrate that today. While the CRL indicates that we have more work to do in refining research-backed guidance on the safety and efficacy of psychedelics use, the extensive feedback typically offered in a CRL is a CLEAR ROADMAP for approval that we could not have imagined 40 years ago, when MDMA was first banned. This marks profound progress, and that is worth celebrating. We now have EVERYONE at the table. While we have spent years debating, wondering, hoping, that the mission of Lykos and the layout of their study would work, we now have EVERY player at the table. It’s a solid discussion now. It’s the real negotiation—-‘Tell us what you need to understand, and how you need it presented so that it feels reliable.’ We now have all sides of the die to take into account. We are no longer rolling the dice, we can now research and disclose every answer to every question on any side we land on. Now…..EVERYONE is in the game. I applaud the efforts of Lykos to be willing to step up and create a study worthy of a CRL. It takes courage to be the one to step in and test the waters. It has been a bold, passionate, and sincere effort. If their study had no legs, there would be nothing to build on. Make no mistake, we are BUILDING. To all those seeking this treatment and feeling discouraged, dismissed, and disheartened, we will continue the work needed to bring this treatment to you. The last player has entered the game. Now we get to build the strategy together. That in itself is monumental. That in itself is hopeful. Hang on. We see you. We are not done.  We will get there.  And until we do….we are still here to help everyone in their healing process in all ways available. https://lnkd.in/eHrUSCUb

Colorado's Department of Revenue has finalized rules for psychedelic-assisted therapy, marking a significant step towards a new model of mental health care in the state. This innovative approach represents a paradigm shift in mental health services by utilizing psychedelics to catalyze patient-led healing, offering a potentially more efficacious and side-effect-reduced alternative to traditional treatments. With regulations in place, Colorado is poised to see the launch of psilocybin therapy in 2025, emphasizing the importance of proper training, integration, and support in this transformative therapy model. #PsychedelicTherapy #MentalHealthCare #BiohackingInnovation #PsychedelicResearch #TherapeuticFramework Read more here: https://lnkd.in/emVWea-d BioMedHack.com is your leading source for the latest news, breakthroughs, and insights in medicine, biohacking, and alternative medicine. Our mission is to help you live healthier and longer by bringing you cutting-edge information and expert advice. Follow us on Facebook, Instagram, and X.

A great read, featuring insight from Dayton neurologist, Dr. Jon Durrani! “PGx helps clinicians to continuously consider the ramifications of gene-drug interactions, especially for patients suffering from other comorbidities.” #healthybrain #neuroscience #mentalhealth #pgx #tempus