Psychedelics Briefs: Cybin, Novamind, Revitalist

Biopharmaceutical firm Cybin announced that the US Food and Drug Administration has authorized a Phase 2 clinical trial to evaluate psychedelic-assisted psychotherapy with psilocybin for frontline clinicians who are experiencing COVID-related distress. The trial will be conducted at the University of Washington, and it will be designed to treat symptoms of depression, anxiety, burnout, and post-traumatic stress disorder.

Anthony Back, MD, who received an investigational new drug approval letter from the FDA that provides authority to move forward with the Phase 2 trial, will serve as its principal investigator.

The trial will enroll 30 frontline clinicians with clinically significant symptoms of depression and anxiety and existential distress following work exposure during the pandemic. The primary outcome will be a comparison of 2 groups—1 that receives the psilocybin-assisted treatment and a placebo group—at 4 weeks post-dose session. A secondary outcome will be a comparison of the groups in symptoms of existential distress.

Novamind Opens New Clinic in Salt Lake City

Novamind, a mental health company specializing in psychedelic medicine, has opened a new clinic in Salt Lake City, Utah. The facility, Novamind’s 7th overall, will focus on treating substance use disorders and addiction-related illnesses. The clinic will be led by incoming medical director Amy de la Garza, MD, a board-certified physician with 10 years of experience in behavioral health and substance use disorder diagnoses and offers outpatient SUD services as an alternative to inpatient treatment.

Novamind plans to collect clinical data on the efficacy of its integrative treatment approach for SUD and host upcoming studies for conditions including opioid use disorder. The Salt Lake City clinical will also pilot a group medical visit that has been shown to improve outcomes in other chronic conditions, including cardiovascular disease and diabetes.

Revitalist to Add Treatment Clinic in Florida

Revitalist Lifestyle and Wellness has signed a lease for its 9th psychedelic-assisted psychotherapy clinic, to be located in Jacksonville, Florida. Slated to open by the end of the month, the new location will include 12 infusion rooms and offer a full suite of treatments, including IV ketamine infusions, vitamin infusions, medication infusions, intensive outpatient programs, ketamine-assisted psychotherapy, esketamine treatments, telemedicine therapy sessions, and transcranial magnetic stimulation.

With the opening of the Jacksonville facility, the Revitalist portfolio will have programs in 6 states with a total capacity of 121 treatment rooms.