NYU Langone Health
This trial is designed to evaluate efficacy and psychological mechanisms of single-dose psilocybin-assisted psychotherapy (PAP) to treat fear of cancer recurrence (FCR), psychiatric (anxiety, depression) distress and quality-of-life (QOL), in 100 outpatients with early-stage breast cancer. The study will assess the strength and durability of therapeutic effects in a double-blind, parallel-design, placebo-controlled, two-center randomized controlled trial (RCT) comparing a single 25mg oral 'high' dose of psilocybin to a single 5mg oral 'low dose psilocybin (active placebo), both delivered in conjunction with a psychotherapy platform.
Inclusion Criteria: * Aged ≥ 21 * Females * Diagnosis of Stage 1 or 2 Estrogen/Progesterone Receptor-Positive (ER/PR +), Human Epidermal growth factor Receptor 2 negative (HER2-) breast cancer * Having completed initial treatment (e.g. surgery, chemotherapy, radiotherapy) for breast cancer (ongoing adjuvant endocrine, and/or HER2 therapy allowed) * At least 1 year after completing initial treatment * Clinically significant Fear of Cancer Recurrence (FCR) defined as Fear of Cancer Recurrence Inventory (FCRI) \> 20 at Screening * Have an identified support person * Agree to be accompanied home…
Experimental dose
Active comparator dose
Arctuva estimate
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