The Bloom #42 Thursday Free Edition the next step in psychedelic medicine ​

After a few weeks of slower news on the psychedelic research front, it's again moving at the speed of light.

Just 2 days ago, MAPS PBC filed their application with the FDA, which is expected to result in the approval of MDMA-assisted therapy for PTSD in 10 months (though many steps will still need to be taken during this process and after it).

I've also started writing more content for (paying) members exclusively, including a recap on the 'psychological support' vs 'PAT' debate between Compass Pathways and the MIND Foundation, and a research briefing detailing three studies from the last week.

Floris - Founder of Blossom

ps Psychedelics Today has opened applications for their third cohort of Vital: a 12-month professional certificate training in the elements of psychedelic-informed practice, harm reduction, and integration. Admissions are open now to anyone with any level of licensure — you don’t have to be a practising clinician to apply!

Applications are open until December 20th. Visit Vital and download the course curriculum for more information or to apply.

1 Group psychedelic therapy: empirical estimates of cost-savings and improved access​

This economic analysis (2023) from two psychedelic therapy trials (MDMA-PTSD & psilocybin-MDD) with group and individual therapy aims to assess clinician time, costs, and patient access. Group therapy demonstrated cost savings of 50.9% for MDMA-PTSD and 34.7% for psilocybin-MDD, potentially reducing the need for full-time equivalent clinicians by 6,711 for MDMA-PTSD and 1,159 for psilocybin-MDD in the U.S., leading to projected savings of up to $10.3 billion and $2.0 billion, respectively, over ten years. Adopting group therapy protocols is suggested to enhance efficiency, reduce costs, and address the shortage of trained clinicians, thereby improving access to psychedelic-assisted therapies.

2 5-MeO-DMT: An atypical psychedelic with unique pharmacology, phenomenology & risk?​

This review (2023) of 5-MeO-DMT, a tryptamine with unique antidepressant potential, notes its distinct effects compared to typical psychedelics. It draws parallels between 5-MeO-DMT's effects and epileptiform activity, particularly through 5-HT1A receptor interactions, suggesting its therapeutic action may resemble electroconvulsive therapy (ECT).

3 Perceptions of psychedelic personality change, determinants of use, setting and drug moderation: Toward a holistic model​

This survey (n=426) explores psychedelic-mediated personality changes, identifying 52 unique themes and 8 factors like Unitive Spiritual and Emotional Stability. It finds psychedelic users more open, extraverted, and less neurotic than non-users. The study suggests a model linking personality to psychedelic use and its impact on personality, emphasizing the need for holistic measures in psychedelic-assisted therapeutics.

More new research

• ​Single-Dose Synthetic Psilocybin With Psychotherapy for Treatment-Resistant Bipolar Type II Major Depressive Episodes​
• ​Acute psychotropic, autonomic, and endocrine effects of 5,6-methylenedioxy-2-aminoindane (MDAI) compared with 3,4-methylenedioxymethamphetamine (MDMA) in human volunteers: A self-administration study​
• ​Ayahuasca in the treatment of posttraumatic stress disorder: Mixed-methods case series evaluation in military combat veterans​

New on Blossom

1 Blossom Pro: Research Briefing #1 - 5-MeO-DMT, Group psychedelic therapy, and personality changes​​

Explore the latest in psychedelic research: cost-effective group therapy models, unique effects of 5-MeO-DMT, and personality changes post-experience.

2 The Ethical Compass of Minding to Psychotherapy: How Much Support is Necessary?​

A battle of Compass Pathways (Guy Goodwin) vs the MIND Foundation (Max Wolff). The need for psychotherapy or just psychological support.

3 The Nature of Drugs – Volume 2​

The Nature of Drugs – Volume 2 – by Alexander ‘Sasha’ Shulgin gives you a deep dive into the excellent lecture series that Sasha gave in the late ’80s. The lectures provide an overview of how the body works and how drugs (including psychedelics) influence it. Throughout the book, you are greeted with a positive attitude, an alchemic way of teaching, Sasha’s joking demeanour, and poignant criticism of drug laws that would still apply today.

4 Psychedelic Research Links December 2023​​

All the other papers that have come out this month we didn't add to the database.

Spotlight

1 BREAKING: MAPS PBC Files New Drug Application for MDMA-Assisted Therapy for PTSD (Article)

MAPS Public Benefit Corporation (PBC) has submitted a New Drug Application (NDA) to the FDA for the approval of MDMA-assisted therapy (MDMA-AT) for PTSD, marking a significant milestone for the organization and its parent non-profit, MAPS.

This submission is the first for a psychedelic-assisted therapy to the FDA. The review process is expected to be complex and could take 6 to 10 months, possibly longer due to MDMA being a new molecular entity and the anticipated need for a Risk Evaluation and Mitigation Strategy (REMS).

However, MDMA-AT's Breakthrough Therapy Designation and a Special Protocol Assessment from 2017 may expedite the process. Approval could come as early as late 2024, with the potential for the first patients to receive therapy by the end of the year or early 2025.

Post-approval, the Drug Enforcement Administration (DEA) will need to reschedule MDMA, and MAPS PBC may be required to conduct further studies, such as in pediatric populations.

Molenvaart 76, Anna Paulowna, NH 1761AL
​Unsubscribe · Preferences​