A Phase 1b Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence

This Phase Ib interventional trial (n=20) will test whether psilocybin (25mg) combined with psychotherapy can reduce fear of recurrence in women with early breast cancer and ovarian cancer in remission.

Conducted by the University of Colorado, Denver, this study aims to determine if psilocybin-assisted therapy can improve fear of cancer recurrence, anxiety, depression, and quality of life.

Participants will undergo preparatory therapy sessions, receive a moderately high dose of psilocybin in a monitored setting, and then complete four integration therapy sessions. Surveys will be used to measure changes in fear of recurrence, depression, anxiety, cancer-related existential distress, quality of life, and spirituality at various points up to 24 weeks.

The study, involving women aged 21 and older, will start in December 2024 and is expected to be completed by December 2028.

Topic Palliative Care Anxiety Depression
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 December 2024
End date 31 December 2028
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 20
Sex Female
Age 21- 99
Therapy Yes

Trial Details

The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question[s] it aims to answer [is/are]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.

NCT Number NCT06430541

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.