Psilocybin Therapy in Advanced Cancer

About the Study

This study is looking at whether psilocybin-assisted psychotherapy may help people with advanced cancer who are experiencing significant anxiety, depression, or emotional and spiritual distress related to their cancer. Psilocybin is a substance that can temporarily change a person's thoughts, emotions, and perception. In this study, psilocybin is given as a single dose together with psychotherapy and support from trained and qualified therapists. Researchers will compare psilocybin with a placebo to better study and understand whether psilocybin psychotherapy can reduce anxiety and other forms of stress. The study is not testing psilocybin as a treatment for the cancer itself. Instead, researchers are studying whether it can help address some of the emotional and psychological challenges that can occur with advanced cancer.

What the Study Involves

This is a Phase 2b randomized, double-blind, placebo-controlled study. People who participate are randomly assigned to receive either:

• Psilocybin, or
• Niacin, an inactive/active placebo used for comparison.

Neither the participant nor the research workers assessing the outcomes knows which treatment the participant receives during the blinded portion of the study. Both groups also receive psychotherapy.

The study is designed to enroll approximately 200 people with advanced cancer.

Participants receive one oral dose of either psilocybin or the placebo during a supervised medication session. The medication is given as part of a psychotherapy program designed to help with anxiety, depression, and distress related to advanced cancer. Participants will be closely monitored by the research team during and after the medication session. Researchers will assess changes in anxiety, depression, emotional distress, and quality of life over time.

The University of Colorado study information indicates that the main portion of the study involves multiple visits and that eligible participants may have the option to continue into an additional open-label extension phase. If a participant takes part in both portions, the entire study may last 28–39 weeks.

What Researchers Hope to Learn

Researchers want to learn whether psilocybin-assisted psychotherapy can:

• Reduce anxiety associated with advanced cancer
• Reduce depression and emotional distress
• Reduce existential distress, such as loss of meaning, hopelessness, or fear related to death
• Improve quality of life
• Better understand how psychological changes associated with psilocybin-assisted therapy may contribute to improvements in emotional well-being

This study is investigating whether this approach may be helpful; it is not yet established as a standard treatment for emotional distress associated with advanced cancer.

Adults who:

• Are 21 years or older
• Have advanced cancer, which may include stage 3 or 4 cancer, metastatic cancer, recurrent cancer, or certain advanced blood cancers
• Are experiencing significant anxiety
• Are well enough to participate in the study activities
• Have a support person who can accompany them home after the psilocybin or placebo session
• Are willing to follow the study's requirements regarding medications and contraception, when applicable

People may not qualify if they have a medical or psychiatric condition that could make participation unsafe. Examples include:

• Certain serious heart conditions or abnormal heart rhythms
• Uncontrolled high blood pressure
• Severe kidney, liver, or breathing problems
• Certain conditions affecting the brain or nervous system
• Certain psychotic or psychiatric conditions
• Pregnancy or breastfeeding
• Certain medications or substance use that could interact with psilocybin

The research team will review a person's medical history to determine whether the study is appropriate.