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NCT06644170
A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer
Phase 1 trial testing Behavioral Intervention in Hematopoietic and Lymphatic System Neoplasm in 15 participants. Completed in 30 September 2025.
30 September 2025
Quick facts
| Lead sponsor | University of Washington |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 19 November 2024 |
| Primary completion | 30 September 2025 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Behavioral Intervention
- Group Therapy
- Psilocybin — full drug profile →
- Questionnaire Administration
Conditions studied
- Hematopoietic and Lymphatic System Neoplasm — all drugs for Hematopoietic and Lymphatic System Neoplasm →
- Metastatic Malignant Solid Neoplasm — all drugs for Metastatic Malignant Solid Neoplasm →
Sponsor
University of Washington
Who can join
Adults 18 to 85, any sex, with Hematopoietic and Lymphatic System Neoplasm or Metastatic Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and had a partial response to their first retreat. Up to 50% of patients with metastatic cancer have clinically significant anxiety and unaddressed anxiety and distress may add to the suffering caused by cancer itself. Psilocybin, a psychedelic drug, is made using an extract from the psilocybe mushroom, also known as "magic mushrooms". Psilocybin binds to serotonin receptors (natural body chemicals that control moods) on brain cells producing intense changes in mood, including anxiety. This may change perceptions and patterns of thinking in ways that may decrease anxiety. Group therapy may reduce stress and improve the well-being and quality of life of patients with metastatic cancer. A second episode of psilocybin-assisted group therapy may be safe, tolerable and or effective in treating anxiety and distress in partial responders with metastatic cancer.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A phase 1 study of a second experience with Group Retreat Psilocybin Therapy for partial responders after a first experience.
Back AL, McGregor BA, Thorn LL, Harvey K, et al · · 2026 · PMID 42058096 · DOI 10.3389/fpubh.2026.1810904
Verify or expand the search:
- PubMed search for NCT06644170
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06644170 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Washington
- Last refreshed: 14 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06644170.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing