Mental health company specialized in psychedelic medicine Novamind Inc. (CSE:NM) (OTCQB:NVMDF) (FSE:HN2) has been selected by the Ketamine Research Foundation to host a phase II clinical trial investigating ketamine-assisted psychotherapy (KAP) for adults with life-threatening illness.
The FDA approval of the study's KAP protocol marks a first in the investigation of KAP for end-of-life patients and its potential to serve as a model of care for this difficult-to-treat population, the company said Thursday.
The Conscious Dying/Conscious Living Trial is sponsored by the KRF, a non-profit leader in ketamine research, advocacy and clinical training.
Over the course of six weeks, study participants will undergo two KAP sessions at Novamind's Murray, Utah research site under the supervision of clinical experts.
Phil Wolfson, MD, founder and CEO of KRF and a pioneering practitioner and instructor of KAP said that “with FDA approval, we're hopeful that this ground-breaking study will demonstrate KAP's potential to relieve distress and serve as a model for practitioners of palliative care, hospice and mental health professionals engaged with those who are facing death, to assist in their attitudes and choices for their remaining time."
Wolfson is also a principal investigator for the Multidisciplinary Association for Psychedelic Studies (MAPS)-sponsored phase II study of MDMA-assisted psychotherapy for individuals with significant anxiety due to life-threatening illnesses.
The mental health toll of a terminal illness is well-documented. Overall, between 24% to 70% of patients experience depression with significant negative impacts on quality of life.
For patients with shortened life expectancy, ketamine may reduce symptoms of depression, anxiety and existential distress, and improve quality of life.
"This study is an important addition to the clinical care and research opportunities for patients within the Psychedelic Palliative Care program that we are building at Novamind," Dr. Paul Thielking, chief scientific officer and principal investigator at Novamind's Murray research site, said. "I've worked with this population for most of my career and, unfortunately, I've sometimes felt limited in what I can offer my patients to ease their emotional distress. The findings will contribute to the evidence for using KAP with patients who have a life-threatening illness and offer new insights into alternative treatments."
