Patients experiencing emotional distress and with stage IV solid tumour cancer will be included in the study. Credit: Africa Studio/Shutterstock.com.

MindBio Therapeutics has started enrolling patients in its Phase II trial evaluating microdoses of lysergic acid diethylamide (LSD) combined with meaning-centred psychotherapy in advanced-stage cancer patients experiencing emotional distress.

The initiation of the study is based on the ethics approval received last month.

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The six-week placebo-controlled, double-blind, randomised study of 40 participants is claimed to be the world’s first LSD take-home trial.

Patients experiencing emotional distress and with stage IV solid tumour cancer will be included in the study.

Advanced-stage cancer patients often develop constant, clinically important, symptoms of psychological distress.

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Such patients also experience a high prevalence of depression, anxiety and minimised quality of life and 40% of those meet the mood disorder criteria.

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These disorders can highly impact a patient’s end-of-life experience and can trigger feelings of loss of meaning, hope, or a desire for hastened death, considered as one of the most challenging problems in palliative medicine.

Anxiety and depression in these patients have also been associated with increased suicidality, prolonged hospitalisation, decreased quality of life and treatment adherence.

Depression is considered to be an independent factor in the risk of early death in cancer patients.

MindBio Therapeutics co-founder and CEO Justin Hanka said: “This research proposes to completely change the way we treat the mental health of cancer patients.

“End-of-life distress is devastating to patients and their families and psychedelics are known to completely transform an individual’s psychological state near the end of life.

“We already know that our LSD-microdosing treatments are well tolerated and effective at elevating mood and improving sleep, our thesis is that small doses of psychedelics will be well tolerated and highly beneficial to this vulnerable patient group.”