PSILOCYBIN FOR PATIENTS

Compelling clinical research data to date have demonstrated the transformative nature of psilocybin drug treatment to help patients suffering with substance use disorders and significant mental health conditions.

The novel combination of psilocybin drug administration in the presence of a trained counsellor is a paradigm shift for the substance abuse disorder and mental health treatment sector. These patients have had no significant new treatment options offered to them for a number of decades.

CLAIRVOYANT’S REGULATORY STRATEGY

Clairvoyant is focused on the clinical validation of psilocybin in Canada, the EU and the UK.

Our regulatory strategy is to obtain approval in alcohol use disorder (AUD) and to expand into other substance abuse disorder indications in parallel:

• Alcohol is the leading risk factor for overall burden of disease among men and a significant risk factor among women.¹

• According to the World Health Organization, 283 million people aged 15 years and older are at risk of AUD.²

• Globally, mortality for alcohol consumption is higher than from diseases such as tuberculosis, HIV/AIDS, and diabetes.²

• A regional study recently reported that fewer than 5 per cent of patients diagnosed with moderate to severe alcohol use disorder receive recommended medications.³

Randomized Clinical Trial data published in 2022 in JAMA Psychiatry showed that two doses of psilocybin reduce heavy drinking by 83 per cent on average among heavy drinkers when combined with psychotherapy. This 2022 data is supported by a psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study in 2015.

These encouraging clinical trial results related to the use of psilocybin for the treatment of AUD help validate Clairvoyant’s own clinical trial approach.

Support for the use of psilocybin as a therapeutic agent is growing and we plan to expand into other substance abuse disorder indications.

CLAIRVOYANT’S CLINICAL TRIAL (CLA-PSY-201)

CLA-PSY-201 is a 24-week Phase 2b clinical trial of synthetic psilocybin treatment for AUD (two dosing sessions of 25 mg oral capsule over 8 weeks) at 12 active clinical sites in Canada and Europe.

See further info on our trial at clinicaltrials.gov listing here.

Clairvoyant is committed to ensuring the safety and well-being of participants. Participants are supported by two therapists in preparation for, and during, the psychedelic experience. Clairvoyant has trained over 50 therapists in its 35-hour training program.

Therapists are monitored for adherence to the trial protocol and ethics under Clairvoyant’s industry leading therapist adherence monitoring program.