Actively Recruiting
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Led by Psyence Australia Pty Ltd · Updated on 2026-03-03
87
Participants Needed
3
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years (inclusive) at screening
- Diagnosed with adjustment disorder due to cancer diagnosis, confirmed by ADNM-20 score ≥ 47.5 and Distress Thermometer score ≥ 4
- Moderate anxiety with Hamilton Anxiety Rating Scale score ≥ 18
- Diagnosed with cancer (excluding specified cancer types in exclusion criteria) with minimum life expectancy of 6 months and ECOG performance status of 0-2
- Agree not to start new psychiatric medications or psychotherapies from screening to Week 10
- Able to communicate well and follow study procedures in English
- Judged to be low suicide risk by Sheehan Suicide Tracking Scale and psychiatrist
- Medically suitable as determined by interview, physical exam, ECG, and blood tests
- Have access to a compatible smartphone or tablet
- Agree not to take sedating medications for at least 12 hours before dosing session (except cancer-related pain meds)
- Willing and able to refrain from smoking during dosing session
- Agree to avoid illegal drugs, non-prescription medications, supplements, and psilocybin outside study from 1 week before dosing through Week 10
- Medications not explicitly excluded will be reviewed for inclusion based on clinical judgement
You will not qualify if you...
- Current major depressive disorder independent of cancer, schizophrenia, bipolar disorder I or II, psychotic disorders, delusional disorder, paranoid or borderline personality disorder, antisocial personality disorder, or judged unsafe for psilocybin therapy
- First-degree relative with diagnosed psychotic disorder
- Clinically significant suicide risk based on Sheehan Suicide Tracking Scale or psychiatrist assessment
- Suicide attempt within 12 months before screening
- Current moderate or severe alcohol or drug misuse, or unwilling to abstain from alcohol 12 hours before dosing
- Unable to engage in therapeutic preparation or integration sessions
- Use of psilocybin microdosing within 5 days or higher dose within 30 days prior to baseline, or use of classic psychedelics within 3 months
- Diagnosed with brain metastases, glioblastoma, or other specified serious medical conditions
- Taking or planning to take antipsychotics, monoamine-oxidase inhibitors, anticonvulsants, or mood stabilizers unless discontinued per protocol
- Fungal allergy
- Positive pregnancy test, breastfeeding, or unwilling/unable to use effective contraception
- Diagnosis of epilepsy or high seizure risk
- Recent cardiovascular events or uncontrolled cardiovascular conditions
- Clinically significant abnormal findings on physical exam, vital signs, ECG, or alcohol breath test
- Liver dysfunction or impaired renal function unless related to cancer and deemed safe
- Any clinically significant illness that poses risk or affects study interpretation
- BMI below 18 or above 32 kg/m2
- Organic brain injury or diagnosed cognitive impairment
- Positive urine drug test for non-prescribed psychoactive substances at dosing
- Participation in another investigational drug study within 3 months before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Mind Medicine Australia Clinic
Abbotsford, Victoria, Australia, 3067
Actively Recruiting
2
Paratus Clinical Research Melbourne
Northcote, Victoria, Australia, 3070
Actively Recruiting
3
Empax Centre
Leederville, Western Australia, Australia, 6007
Actively Recruiting
Research Team
T
Tim Waugh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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