Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission
University of Colorado, Denver
Summary
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.
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1, Aged ≥ 21 2. Diagnosis of: * early-stage breast cancer at low risk of recurrence * defined as clinical stage 1 or 2 * completed primary treatment (surgery, chemotherapy \[adjuvant, patients may continue to be treated with neoadjuvant\], and/or radiation) \> 6 months ago * oncologist reported risk of recurrence at 10 years \< 20% * late-stage ovarian cancer at high risk of recurrence * defined as Clinical stage 3 or 4 * currently in remission * oncologist reported risk of recurrence at 10 years \> 80% 2. Functional Status defined as: * Eastern Cooperative…
Interventions
- DrugPsilocybin
A tryptamine that produces its behavioral effects primarily by acting as post-synaptic agonists at serotonin 5-HT2A and 5-HT2c receptors.
Locations (2)
- Outpatient CTRCAurora, Colorado
- University of Colorado Cancer CenterAurora, Colorado