Numinus and MAPS reach trial milestone
In a first-of-its-kind trial in Canada, Numinus Wellness (CSE: NUMI) has partnered with MAPS Public Benefit Corporation to collaborate for research on MDMA-assisted therapy. The “single-arm, open-label, compassionate access 1” trial has met several key milestones to enter a pre-implementation stage.
Aiming to expand access and treatment options to patients with PTSD, these significant developments will help gain better understanding of psychedelic-assisted psychotherapies as viable, safe, and necessary.
Who’s who?
- Eight Numinus therapists working on this trial graduated in November 2020 from Part B of the MAPS-standardized MDMA therapist training program.
- Dr. Devon Christie, Medical & Therapeutic Services Director at Numinus, was trained in this program and will serve as both the trial’s Principal Investigator and as a therapist.
- MAPS Public Benefit Corporation, a subsidiary of MAPS, was formed to develop healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics.
Neither the FDA or Health Canada have approved this therapy just yet. The safety and efficacy of MDMA-assisted psychotherapy are still under investigation.
NYU Langone and MindMed launch psychedelic center
Operating with an endorsement by NYU Langone’s Department of Psychiatry, the one-of-a-kind health center continues to advance progress in psychedelic medicine through their Psychedelic Medicine Research Training Program.
The program will support development of early-career faculty members and post-doctoral fellows to become independent investigators in the field of psychedelic medicine. Treatment models & training programs developed at the center will scale psychedelic medicines into mainstream adoption by psychiatrists & therapists in America.
They have a lot going on.
Research at the center has and still focuses on the treatment of advanced cancer-related psychiatric and existential distress, addiction, major depression and PTSD.
- Phase II clinical trial nearing completion to examine the use of psilocybin in treating alcohol use disorder, and developing a Phase II/III trial.
- Phase II study from 2016 is now in Phase III development, with a funding proposal under review with the National Cancer Institute.
- Recruitment underway for Phase II study to evaluate the efficacy of psilocybin in the context of “set and setting” therapy for individuals with major depressive disorder.
- Recently completed a Phase III study on the safety and efficacy of psychotherapy utilizing MDMA for treatment of severe PTSD, and began recruitment for a second Phase III study.
- Other studies are examining the use of psychedelics for disorders including chronic pain, end-of-life psychotherapy, opioid & tobacco addiction, and more.
Philanthropic efforts have kept the momentum going.
Major philanthropic support from donors have enabled medical breakthroughs and totaled over $10 million in support for studies at NYU Langone.
- MindMed (OTCM: MMEDF) leads the way with $5 million contribution.
- Scientist & philanthropist Carey Turnbull: $1 million
- Private investor Alan Fournier: $2 million
- President of the Usona Institute, Bill Linton: $1 million
- Other significant donors include the George Sarlo Foundation, Cody Swift of the Riverstyx Foundation and Dr. Bronner’s Soaps.
Massachusetts is looking to decriminalize all drugs
It’s clear that current drug enforcement regulations are creating an unjust number of arrests and prosecutions in fragile communities. That’s why lawmakers introduced legislation in Massachusetts aiming to end the state’s war on drugs, which has disproportionately targeted racial minorities.
The statewide bill HD.3439 was introduced on Friday to challenge current criminal penalties for the possession of controlled substances in Section 34. These efforts come alongside bills SD.2248 and HD.3829 that aim to solve racial injustice and evaluate the impact of these new regulations.
What are they trying to pass?
- Remove criminal penalties for possession of all drugs.
- Legalize and regulate psychedelic substances, including possession, consumption, transportation, and sale of entheogenic plants and fungi.
- Establish a 21-person task force to conduct studies on entheogenics.
- Civil fine of up to $50, or submitting to screening for health and economic evaluation in order to provide services to the individual rather than an economic punishment.
- Completion of this screening won’t be deemed as an admission of criminal charges.
- Failure to pay the fine won’t incur penalties or incarceration.
What’s up with this “task force”?
- They will develop recommendations:
- On how to legalize psychedelic substances “in a manner that maximizes equitable access and sustainable manufacture of these plants.”
- Regarding “pardons, parole, diversion, expungement, and equity measures” for people with prior criminal records due to possession, or distribution of these substances.
These recommendations will be used to draft legislation to be put into effect no later than June 2022.
UC San Diego researchers are exploring psychedelics to treat phantom limb pain
Imagine losing a limb yet still experiencing chronic pain out of thin air. The phenomena, known as ‘phantom limb’ is a commonly debilitating sensation that a limb is still physically there, because the brain interprets it as such.
The result is lingering pain with no effective solution for up to 80% of the world’s 40 million amputees (according to WHO).
- $1.3 million grant from the Steven & Alexandra Cohen Foundation will fund the first randomized, placebo-controlled human clinical trial into the therapeutic use of psilocybin, specific to phantom limb pain, at the Psychedelics and Health Research Initiative at UC San Diego.
- The UC San Diego Center for Mindfulness intends to replace painkillers with psychedelic-assisted therapeutic treatments.
- The trial is also designed to shed light on mechanisms and faulty circuitry of the brain.
- Military veterans have the highest rates of amputation and chronic phantom limb pain.
Study Details
Timothy Furnish, MD, clinical professor of anesthesiology at UC San Diego School of Medicine had this to say:
- The clinical trial will enroll 30 amputees suffering from phantom pain to receive 25 milligrams of psilocybin; another 30 will receive a placebo (niacin).
The trial will assess pain and psychological functioning, including magnetic resonance imaging.
Awakn announces AUD study results
The world’s first MDMA clinical trial addressing alcohol use disorder (AUD) has now provided definitive, promising results. The outcome of the study conducted by Awakn Life Sciences: all patients tolerated the treatment well, and with no adverse reactions. Further trials will now ensue.
- Dr. Ben Sessa, Chief Medical Officer at Awakn, conducted the Bristol Imperial MDMA in Alcoholism (BIMA) trial.
- The study evaluated patients’ drinking behavior, quality of life and psycho-social functioning.
- Phase IIb study in the UK will now proceed. It will be a double-blind, placebo-controlled clinical trial to further investigate safety and efficacy of MDMA.
This is a really big deal.
- The first clinical research study using MDMA-assisted psychotherapy to treat any addiction, and it was totally successful! Improvements by all measures were clinically observed.
- Currently available treatments are greatly ineffective, with a high rate of relapse.
- Alcohol abuse is the most prevalent substance disorder in the world, and one of the top 5 causes of disease and disability in Europe.
- In the UK, alcohol is the leading cause of diseases for over 20% of the adult population.
- It’s expected that the COVID-19 pandemic will make matters worse.
Report Readout
Frontier Acquisition Corp, a special purpose acquisition company (SPAC) sponsored by German investor Christian Angermayer, a major backer of COMPASS, will launch biotech SPAC in the U.S.
Mindset landed an international contract to develop and manufacture synthetic psilocybin.
Mind Cure adds global technology leader Robert C. Hill to Board of Directors.
Edmonton psychiatry professor founding new company by studying psychedelic effects on mental health.
Columbia professor turns heads with bold statements on his recreational use of drugs.
Psychedelic drug therapy now offered at Calgary clinic to treat depression, anxiety, PTSD.
Universal Ibogaine Inc. announces appointment of Dr. Rami Batal as Chief Executive Officer.
PharmaTher to collaborate with Terasaki Institute for Novel Microneedle Delivery of Psychedelic Pharmaceuticals.
Therapists could be influencing mystic, spiritual experiences and meaning while patients are on psychedelics.
Entheon Biomedical and Science in Action received ethics approval for in vivo non-GLP toxicology study of DMT.
Hawaii bill dies in session, opposed by the state Department of Health as well as county police departments.
Field Trip Health secures $50 million offering of common shares with Bloom Burton Securities Inc.
DEA gives green light for Psilera’s mission to study new DMT and psilocybin treatments for central nervous system disorders.
Optimi Health Corp goes public, completing a $20.7 million IPO.