MAPS-sponsored study on MDMA for PTSD by Numinus gets the go-ahead from Health Canada

Vancouver’s Numinus Wellness announced that Health Canada issued a No Objection Letter to the company, giving them federal approval to proceed with a study evaluating MDMA-assisted therapy for post-traumatic stress disorder (PTSD).

Why it matters: In addition to learning more about the therapy, Numinus will collect safety and efficacy data to help inform Health Canada’s decision on whether to increase access to the therapy. It also puts the infrastructure into place to scale up if needed and permitted.

What to know: 

  • The study is sponsored by and in collaboration with the Multidisciplinary Association for Psychedelic Studies (MAPS), specifically its subsidiary, the MAPS Public Benefit Corporation
  • Building on the May 2021 results from a Phase 3 clinical trial by MAPS that showed the efficacy of MDMA-assisted therapy for PTSD
  • Dr. Devon Christie, the director of Numinus Medical and Therapeutic Services, will be the study’s Qualified Investigator. Dr. Christie is MAPS-trained in MDMA-assisted therapy, a family physician and a certified relational somatic therapist
  • In the preparation phase (training staff, importing meds and applying for ethics clearance to start recruiting participants)

“At Numinus, we are focused on expanding patient access to psychedelic-assisted therapies such as MDMA for PTSD,” said Payton Nyquvest, CEO of Numinus, “and we are gratified that our study will provide safety and outcome data to regulators to support integration of this treatment into mainstream mental health care.”

Bad psychedelic trips still have therapeutic value to some seasoned trippers

A small study published in the International Journal of Drug Policy says people who experience disturbing, bad psychedelic trips report that they still gave them “deep existential and life-altering insights,” reports VICE.

Researchers conducted lengthy, open-ended interviews with 42 men and eight women, all Norwegians, they found in a closed psychedelics Facebook group. Most had used LSD, psilocybin mushrooms, DMT or ayahuasca between 10 to 50 times. Two said they hadn’t ever experienced a bad trip.

Among those who had, most participants reported that:

  • Bad trips usually correlated to larger doses
  • They typically started out as normal, with feelings of connectivity and being uplifted, then became more “challenging,” with fearful feelings and the need to solve a distressing problem
  • Common characteristics of bad trips: anxiety, paranoia, panic attacks, confusion, dizziness, unsteady heartbeat and frightening visuals
  • Despite the unpleasant experiences and emotions, they largely led to valuable insights or teachable moments that help inform future trips

“When I woke up the day after, it was as if I looked at it as a positive experience,” said one participant. “You just breathe out, and [think] ‘fuck, that was a crazy night’. It was special, but the effect is often like that for magic mushrooms and LSD. I mean, after every time I take these drugs, I always look at life more positively.”

Researchers in New Zealand want LSD to be reclassified to make their work easier

LSD is a Class A drug in New Zealand, but scientists and advocates want to see that change so they can more easily conduct research on its potential to treat mental health disorders, writes Newshub.

With so much evidence that LSD has therapeutic benefits and so little showing that there are risks of abuse or addiction, advocates like Amadeus Diamond of the Entheos Foundation wants to see more research on LSD conducted outside of clinical settings.

The government has not expressed interest in altering the Misuse of Drug Act, but researchers like Dr. Lisa Reynolds from the University of Auckland are going to keep pushing.

“I think we have a real opportunity to take this to the Government and say ‘look, let’s be adults, let’s change policy to fit with the evidence.’”

Psyence partners with Contract Research Organization to launch palliative care clinical trial

Toronto-based Psyence announced it’s partnering with leading, UK-based CRO Clerkenwell Health to develop “market leading” clinical trials in psilcybin-assisted palliative care.

The trials will be led by European director Xan Morgan, who will work closely with Clerkenwell and palliative care specialist Dr. Dingle Spence in the UK to design and deliver them.

“There is an historic opportunity for psychedelics such as psilocybin to play a significant role in palliative care,” said Spence. 

“We are interested in helping alleviate the many symptoms and conditions experienced by people dealing with serious illness including anxiety and depression, existential distress, quality of life concerns, and issues around grief and bereavement, using a Palliative Care lens that will provide a more holistic approach to their therapy.”

Scientists restore mouse brains with ketamine and flickering light

Young people often retain profound or crucial memories that last long into adulthood. That process happens in the brain’s “perineuronal net” during important phases of development. 

Neuroscientist Sandra Siegert and a team at IST Austria because interested in removing the perineuronal net in an effort to restore the brain’s youthful plasticity after noticing that, after repeated ketamine anaesthesia doses, the perineuronal net disappeared in mice, writes Science Daily. They also discovered that repeated 60-hertz repeated flickering light had the same effect.

Why it matters:

  • Previous attempts to remove the perineuronal net are invasive, so less-invasive methods could create a new avenue for human therapy in the future
  • It could be possible to “overwrite” traumatic memories with new ones — but that comes with risks, too
  • Researchers are hoping the new method could help treat amblyopia, also known as lazy eye, which happens in early child development

“There is a lot to explore,” said lead author Alessandro Venturino.