Australia-based MindBio Therapeutics Corp., an ex-subsidiary to Blackhawk Corp. received ethics approval for a Phase 2 clinical trial assessing the effects of LSD microdoses, paired with meaning-centered psychotherapy, on patients with advanced-stage cancer.
The randomized, double-blind, placebo-controlled study follows positive outcomes from a Phase 1 trial on healthy volunteers including increases in energy, social connectivity, creativity, wellness and happiness as well as tolerance to the LSD microdoses.
CEO Justin Hanka said the clinical data collected so far has exceeded the company’s expectations and “shows much promise” for treating patients with depression or anxiety experiencing diminished mood, compromised well-being and low energy.
Reportedly “the world's first LSD take-home 6-week trial,” the Phase 2 study will involve 40 patients with stage-IV solid tumor cancer and experiencing emotional distress showing symptoms of anxiety and depression.
See also: New Zealand Government Grants $650K For LSD Microdosing Trials
People with advanced-stage cancer have a high prevalence of depression, anxiety and reduced quality of life with 40% meeting the criteria for a mood disorder, which can contribute to feelings of loss of meaning, hope or a desire for hastened death.
While existential distress is considered one of the most challenging problems in palliative medicine, depression and anxiety have been associated with decreased treatment adherence, prolonged hospitalization, decreased quality of life and increased suicidality in this population. Depression is itself an independent risk factor for early death in cancer patients.
The company has published the detailed findings from its Phase 1 trial combining clinical and non-clinical dosing settings in the peer-reviewed journal Biological Psychiatry.
Photo: Benzinga edit with photo by fizkes and olesea vetrila on Shutterstock.
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