MindBio Therapeutics has received ethics approval for a Phase II trial of microdoses of Lysergic Acid Diethylamide (LSD) and Meaning Centred Psychotherapy for the treatment of patients with advanced-stage cancer.

Meaning Centred Psychotherapy is a psychotherapeutic intervention used to treat advanced cancer patients living with symptoms of anxiety and or depression.

The randomised double-blind and placebo-controlled trial will include 40 patients in total.

During the trial, patients with stage IV solid tumour cancer and undergoing emotional distress will be randomised to receive the treatment.

The six-week trial is claimed to be the world’s first take-home LSD-microdosing study in cancer patients with emotional distress.

Cancer patients often develop constant, clinically important, symptoms of psychological distress.

Advanced-stage cancer patients experience a high prevalence of depression, anxiety and minimised quality of life and 40% of those patients are estimated to meet the mood disorder criteria.

Those disorders can highly affect a patient’s end-of-life experience and can trigger feelings of loss of meaning, hope or wish for faster death.

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

Data from a Phase I trial showed that LSD-microdosing increases energy, social connectivity, creativity, wellness and happiness levels in healthy participants. Microdoses of LSD were also found to be well tolerated.

MindBio Therapeutics CEO Justin Hanka said: “The data we have collected in our clinical trials has exceeded our expectations and shows much promise for treating patients with mental health conditions such as depression and anxiety where diminished mood, compromised well-being and low energy is experienced.”