A Phase 1b Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence
Phase 1b single-group interventional study (n=20) testing a single 25 mg dose of psilocybin with manualized psychotherapy to reduce fear of cancer recurrence in women with early breast cancer or ovarian cancer in remission.
Details
This single-group Phase 1b study will assess whether a single 25 mg oral dose of cGMP psilocybin combined with preparatory and integrative psychotherapy reduces fear of cancer recurrence in women previously treated for early breast cancer or ovarian cancer in remission.
Participants complete preparatory therapy, a monitored dosing session, and four integrative therapy sessions; outcomes include measures of fear of recurrence, anxiety, depression, and quality of life.
Safety screening excludes unstable medical conditions, significant CNS pathology, primary psychotic disorders, recent heavy hallucinogen use, active moderate/severe substance use disorder, significant suicidality, pregnancy, and interacting medications.