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Life sciences · Phase 2 Trial
ClinicalTrials.gov · November 2, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07909408). This is a study registration, not published results. Lead sponsor: NYU Langone Health. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Early-stage Breast Cancer, Fear of Cancer Recurrence, Anxiety, Depression. Interventions: DRUG: Psilocybin 25 mg; DRUG: Psilocybin 5 mg. Primary outcome measures: Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) , Baseline, Week 4 Post-Dose Session. Brief summary: 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.