Psilocybin Therapy for Advanced Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.
Do I need to stop my current medications to join the trial?
Yes, you may need to stop certain medications to join the trial. You cannot take antidepressants, certain mood stabilizers, antipsychotics, or centrally-acting serotonergic agents. If you are taking niacin, you must stop at least five days before the trial. However, prescribed opiates and benzodiazepines can continue if you've been on a stable dose for a specified period.
What data supports the effectiveness of this drug for advanced cancer?
Is psilocybin therapy generally safe for humans?
Psilocybin, found in magic mushrooms, can cause challenging experiences, but when used in controlled settings with support, the risk of lasting psychological distress or risky behavior is very low. Some studies suggest that psilocybin does not worsen certain heart conditions and may even protect against cell injury, but caution is advised with higher doses.16789
How is psilocybin therapy different from other treatments for advanced cancer?
Psilocybin therapy is unique because it uses a psychedelic compound found in certain mushrooms to potentially improve mental well-being and reduce anxiety in patients with advanced cancer, unlike traditional treatments that focus primarily on physical symptoms. It is not yet approved for therapeutic use in the U.S., but it has shown promise in palliative care by providing long-term improvements in mood and quality of life with minimal side effects.124510
Eligibility Criteria
Adults aged 21+ with advanced stage 3 or 4 cancer experiencing significant depression, anxiety, or existential distress. They must have a support person and agree to use birth control if of childbearing potential. Excluded are those with certain psychiatric disorders, severe heart conditions, epilepsy, dementia, high suicide risk, drug abuse history within the past year, and those on conflicting medications.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of psilocybin (25mg) or niacin (100mg) along with psychotherapy to treat anxiety, depression, and existential distress
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Niacin 100mg (Other)
- Psilocybin (Psychedelic)
- Psychotherapy (Behavioural Intervention)
Psilocybin is already approved in United States, European Union for the following indications:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
- Treatment-resistant depression (TRD) under PRIME designation