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Psychedelics

Division Launch Announcement – March 30, 2021

After decades of scientific suppression, a handful of intrepid researchers have pushed through major barriers to examine the power of psychedelic therapy to treat the ailing human mind. Their research has recovered a path towards a particularly deep quality of care and healing.

The timeliness of these advances cannot be overstated. Over half a billion people on our planet are suffering from the debilitating effects of mental health conditions, and the burden is increasing. Meanwhile, we continue to recycle the same short list of modestly effective, side-effect inducing drugs. We can do better.

The Neuroscape Psychedelics Division is dedicated to advancing the field of psychedelic science and medicine through multi-level research covering basic to translational to clinical science. Our research is dedicated to the delivery of breakthrough discoveries in psychiatry, neurology and neuroscience.

Robin Carhart-Harris
Director, Psychedelics Division

Basic Science

The advancement of all novel therapeutics is aided by a deep appreciation of their underlying mechanism of action. Over the last several decades, we have developed a scientific basis for how psychedelics result in beneficial effects across a wide range of clinical conditions, but there are still major gaps in our understanding. The Neuroscape Psychedelics Division, hand-in hand with our Neuroscience Division, will advance the basic science behind the positive effects of psychedelics on the brain and behavior by studying their influence on neural network dynamics and long-term neuroplasticity in healthy human research participants.

Our upcoming studies will involve comprehensive observations of neural and physiological signatures before, during, and after psychedelic treatments. This goal will be aided by Neuroscape’s Multimodal Biosensing Program, which achieves simultaneous recording of multiple signals via fMRI, EEG, ECG, EOG, EMG, EDA, respiratory and facial expression tracking integrated with advances in signal processing and machine learning.

Clinical Science

Since the 1950’s medical scientists have been documenting meaningful and sustainable clinical benefits from psychedelic therapies in a wide range of patients, including those suffering from depression, anxiety, post-traumatic stress disorder (PTSD) and addiction. The field continues to remarkably advance, now with the Phase 2 and Phase 3 studies that are positioned to lead to the first approvals of psychedelics for clinical conditions.

The Neuroscape Psychedelics Division, in partnership with our Clinical Division, will engage in clinical trials at all stages to better inform both the efficacy and safety of these compounds as medicine.

Members of this team have led the efforts to conduct the first psychedelic studies at UCSF in nearly 20 years and are excited to apply their experience to the Neuroscape Psychedelics Division. They have already completed two MAPS sponsored clinical trials for MDMA-Assisted Therapy, as well as an open-label study investigating psilocybin for demoralization, detailed below.

  1. An Open-Label, Multi-Site Phase 2 Study of the Safety and Effect of Manualized MDMA-Assisted (published)
  2. A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder (in press)
  3. An Open-label pilot study of psilocybin-assisted group psychotherapy for demoralization in long-term AIDS survivors (published)

 

Currently the Psychedelics Division is a site for an additional Phase 3 clinical trial investigating the therapeutic effects of MDMA-assisted therapy for PTSD in participants with moderate to severe PTSD and is also the central site for the long term follow-up study for participants who have gone through an MDMA-assisted therapy study. This long term follow up study will assess the durability and long term safety and effectiveness of the treatment. Both trials are led by led by Jennifer Mitchell.

  1. A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder of Moderate or Greater Severity
  2. Long-Term Safety and Persistence of Effectiveness of Manualized MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder

 

Additionally this team will be taking part in an extension study where participants who received placebo in the Phase 3 MDMA studies will have the opportunity to receive MDMA. Additionally, studies of psilocybin for end-of-life distress and alcohol use disorder (AUD) are now in development:

  1. A Multi-Site Open-Label Safety Extension Study of Manualized MDMA-Assisted Therapy for the Treatment of Participants with Posttraumatic Stress Disorder

 

Project Personnel:

  • Jennifer Mitchell
  • Catriona Miller
  • Dawn Weinstein
  • Allison Coker
  • Brian Anderson
  • Sydney Griffith
  • Catherine Gotz
  • Jessica Schachtner

Psychedelic Session Facilitators:

  • Debbie McDivitt
  • Sylver Quevedo
  • Andrea Rosati
  • Evan Sola
  • Jordan Eipper
  • Leana Smith
  • Alexandra Hass
  • LaMisha Hill

Translational Science

Psychedelics are unique amongst pharmacological therapeutics in that their clinical impact is greatly influenced by contextual elements, which serve to shape a participant’s acute experience and impact their long-term outcomes. This is referred to in the field as “set and setting” and suggests that psychedelics should be viewed as a form of experiential medicine. Despite recent scientific breakthroughs in both mechanism and clinical efficacy, there is a surprising lack of innovative research into the delivery of the psychedelic experience.

The Neuroscape Psychedelics Division, working closely with our Technology Division, will capitalize on this major opportunity to advance psychedelics as precise and personalized therapeutics by studying how set and setting can be optimized to improve treatment effects in clinical populations. This will be accomplished via the collection of neural and physiological data to provide a rich map of a participant’s real-time state as the experience unfolds over time, coupled with dynamic adjustments of key contextual elements (e.g., sights, sounds and smells) in a manner that fosters enduring positive outcomes.

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