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RecruitingNCT07072728

Psilocybin-assisted therapy for anxiety related to cancer

Living with cancer can sometimes lead to significant anxiety and difficulties adjusting to changes in everyday life. This clinical trial is investigating whether psilocybin, combined with psychotherapy, may help adults experiencing adjustment disorder related to cancer. This treatment is experimental; taking part does not guarantee improvement.

Adjustment disorderDrugFrom 18 Years to 80 Years
In plain English

Key information made simple

Who can participate?

Adults aged 18–80 with cancer-related adjustment disorder and at least moderate anxiety may be considered. Additional medical and mental health criteria apply; the research team makes the final eligibility decision.

What is being studied?

The study compares 25 mg, 10 mg and 1 mg doses of investigational psilocybin (NPX-5), combined with psychotherapy and medical supervision, to assess safety and effectiveness. Dose allocation is by chance; the 1 mg group is a low-dose comparison group.

What does participation involve?

Screening is followed by three preparation sessions, an approximately eight-hour supervised treatment session, support to process the experience, and follow-up assessments. Participation combines clinic visits and telehealth. Follow-up continues to three months after the final Week 10 visit. Some participants who do not respond may be offered a second cycle if still eligible; this is not guaranteed.

Where is the study taking place?

The following Australian sites are listed as recruiting in ClinicalTrials.gov. Confirm current availability and travel requirements with the research team.

  • Mind Medicine Australia Clinic — Abbotsford, Victoria
  • Neurocentrix — Melbourne, Victoria
  • Ramsay Northside Clinic — Melbourne, Victoria
  • Paratus Clinical Research Melbourne — Northcote, Victoria
  • Empax Centre — Leederville, Western Australia

Is the treatment approved?

NPX-5 is being investigated in this clinical trial. Its safety and effectiveness for this use are still being evaluated. Participation does not guarantee personal benefit.

What should I confirm?

Ask the team about risks, current medicines, the full visit schedule, and any costs or reimbursement. A potentially related ANZCTR record (ACTRN12624000449538, updated 21 April 2025) names PEX010 and has different cancer eligibility and follow-up requirements. It does not cross-reference NCT07072728; the sponsor needs to confirm the relationship and current protocol.

ClinicalTrials.gov — NCT07072728. Registry update: 29 October 2026. Editorial review: 2 November 2026. ANZCTR

Your next step

Check the study details

There are five planned clinic visits per cycle (Days 1, 13, 14, 15 and 70), in addition to screening, plus telehealth preparation, support and follow-up. The treatment session lasts approximately eight hours. Ask the team to confirm the full schedule and whether a second cycle could apply to you.

What happens next?

  1. Explore: Read the study information and the full eligibility criteria in the official registry.
  2. Express interest: Contact the research team using the official registry, or use the HopeStage form to request help reviewing the study.
  3. Screening: The research team checks eligibility and explains the visits, risks and consent process.
  4. Decide: Ask questions and decide whether to participate. HopeStage cannot determine medical eligibility or provide medical advice.

Tim Waugh: tim@psyencebiomed.com · +61481354373

Could this study be relevant to you?

You may be eligible if:

You may not be eligible if:

These are selected criteria, not a complete checklist or an eligibility assessment. The research team reviews all criteria and makes the final decision. Discuss medication requirements with the team and your treating clinician; do not change or stop treatment yourself.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: October 1, 2025
Recruitment status
Recruiting
Enrollment listed in the registry
87
Sponsor
Psyence Australia Pty Ltd
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
Australia
Age range
From 18 Years to 80 Years
Official registry ID
NCT07072728
Official title
Show the full official title

A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.

Want help reviewing this study?

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Study ID: NCT07072728. We help you review the study, but cannot decide medical eligibility.

Recruitment & locations

Recruiting

Abbotsford · Melbourne · Northcote

1 more locations
  • Leederville
Checked Official study record (opens in a new tab)
Registry details
Registry conditions (original wording)

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

FAQ

Questions about this study

What is this study about?

The study compares 25 mg, 10 mg and 1 mg doses of investigational psilocybin (NPX-5), combined with psychotherapy and medical supervision, to assess safety and effectiveness. Dose allocation is by chance; the 1 mg group is a low-dose comparison group.

What will I need to do?

Screening is followed by three preparation sessions, an approximately eight-hour supervised treatment session, support to process the experience, and follow-up assessments. Participation combines clinic visits and telehealth. Follow-up continues to three months after the final Week 10 visit. Some participants who do not respond may be offered a second cycle if still eligible; this is not guaranteed.

Who is behind this study?

The study sponsor is Psyence Australia Pty Ltd.

Who can participate?

Adults aged 18–80 with cancer-related adjustment disorder and at least moderate anxiety may be considered. Additional medical and mental health criteria apply; the research team makes the final eligibility decision.

Is this study still recruiting?

The registry lists this study as recruiting.

Is the treatment approved?

NPX-5 is being investigated in this clinical trial. Its safety and effectiveness for this use are still being evaluated. Participation does not guarantee personal benefit.

What should I know before deciding?

Ask the team about risks, current medicines, the full visit schedule, and any costs or reimbursement. A potentially related ANZCTR record (ACTRN12624000449538, updated 21 April 2025) names PEX010 and has different cancer eligibility and follow-up requirements. It does not cross-reference NCT07072728; the sponsor needs to confirm the relationship and current protocol.

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PEX010 for Adjustment disorder

The registry lists this study as recruiting. Study locations are listed in Australia. Confirm recruitment at each site. It is testing PEX010 for Adjustment disorder.