RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Psilocybin therapy for Adjustment Disorder

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

Official registry: https://clinicaltrials.gov/study/NCT07072728 · Psyence Australia Pty Ltd · enrollment listed as 87

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Psilocybin therapy. The registry lists allocation as randomized. This study is assessing the how well it works and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.

They plan to enroll about 87 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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.

Interventions: Psilocybin therapy

Primary outcome (registry wording): Anxiety Severity

Who it is for (from inclusion criteria)

Ages 18 Years to 80 Years
To be eligible for study entry participants must satisfy all of the following criteria:
Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer
Screening HAM-A Score ≥18 (moderate anxiety)
Adults aged 18 to 80 years (inclusive) at screening
Diagnosed with cancer (exempting those cancers listed in the

Who the registry excludes

) and a minimum life-expectancy of 6 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale performed at screening
Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10
Able to communicate well and follow study procedures, judged as sufficiently competent with the English language by the investigator, able to build adequate rapport with study staff
Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist
Be medically suitable in the opinion of the investigator as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests
Have access to a device that is compatible to use the digital technology, i.e smart-phone device or tablet
Agree not to take any sedating medications for a minimum of 12 hours before the dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and zolpidem. Medications for cancer-related pain are permitted

Public study contact (from the registry)

Tim Waugh

+61481354373

tim@psyencebiomed.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

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

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FAQ about this NCT record

Is NCT07072728 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07072728?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07072728?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary