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Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder

NCT07072728 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-03-03

No results posted yet for this study

Summary

This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.

Who is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder.

Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day).

At Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5.

It is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.

Conditions

  • Adjustment Disorder
  • Adjustment Disorder With Anxious Mood
  • Cancer
  • Cancer Cachexia
  • Cancer of Endometrium
  • Cancer of Kidney
  • Cancer of Prostate
  • Cancer of the Breast
  • Cancer of Stomach
  • Cancer Melanoma Skin
  • Cancer Pancreas

Interventions

DRUG

Psilocybin therapy

Following a screening period, eligible participants will undergo one cycle of psilocybin-assisted psychotherapy (PAP). Non-responders at Week 10 who continue to meet eligibility criteria will be offered a second PAP cycle at the 25 mg NPX-5 dose. A maximum of two PAP cycles may be given. Long-term follow-up will include a visit at Month 3 following the final PAP cycle.

Sponsors & Collaborators

  • Psyence Australia Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Clive Ward-Able · Psyence Biomedical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-12-30
Completion
2027-07-30

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07072728 on ClinicalTrials.gov