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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
Led by Psyence Australia Pty Ltd · Updated on 2026-03-03
87
Participants Needed
3
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of NPX-5 in psilocybin-assisted psychotherapy (PAP) for treating adjustment disorder symptoms caused by the stress of a cancer diagnosis. This Phase IIb randomized, double-blind study involves adults aged 18 to 80 who experience anxiety after adjusting to their cancer diagnosis. The goal is to develop scientific knowledge that may lead to new treatments for anxiety and depression following such stressful events. Participants are randomly assigned to receive one of three doses of NPX-5—25 mg, 10 mg, or 1 mg—during an approximately 8-hour PAP dosing session on Day 14. Those who do not respond by Week 10 and still meet eligibility criteria may receive a second PAP cycle at the 25 mg dose. A maximum of two PAP cycles can be given. The study includes preparation sessions before dosing and follow-up visits after treatment, combining in-person clinic visits and telehealth appointments. Participants will attend screening visits, preparation sessions, dosing and integration sessions, and several follow-up visits up to three months after their final PAP cycle. Assessments include anxiety severity using the Hamilton Anxiety Rating Scale, suicidality monitoring, vital sign checks, and safety evaluations. The study monitors treatment-related adverse events and long-term safety and tolerability of NPX-5, with the final safety follow-up occurring three months after the last treatment cycle.
CONDITIONS
Brief 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 (AjD) due to cancer diagnosis with ADNM-20 score ≥ 47.5 and Distress Thermometer score ≥ 4
- Moderate anxiety with HAM-A score ≥ 18
- Diagnosed with cancer (excluding certain types) and minimum life expectancy of 6 months with ECOG performance status 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
- Low suicide risk based on Sheehan Suicide Tracking Scale and psychiatrist assessment
- Medically suitable based on interview, exam, ECG, and blood tests
- Have access to a compatible smart device
- Agree to avoid sedating medications 12 hours before dosing session
- Willing to refrain from smoking during dosing session
- Agree to avoid illegal drugs, supplements, and psilocybin outside study from 1 week before dosing to Week 10
- Willing to discuss other medications with investigator and medical monitor
You will not qualify if you...
- Current or recent major depressive disorder or psychotic disorders, bipolar disorder, personality disorders, or conditions incompatible with safe psilocybin exposure
- First-degree relative with psychotic disorder
- Clinically significant suicide risk or recent suicide attempt
- Current moderate or severe alcohol or drug misuse
- Unable to engage in therapy sessions
- Recent use of psilocybin or other classic psychedelics within specified timeframes
- Diagnosed with brain metastases, glioblastoma, or certain serious medical conditions
- Taking antipsychotics, monoamine-oxidase inhibitors, anticonvulsants, or mood stabilizers unless discontinued appropriately
- Fungal allergy
- Positive pregnancy or breastfeeding without contraception
- Diagnosis of epilepsy or seizure risk
- Cardiovascular conditions including recent stroke or uncontrolled hypertension
- Clinically significant physical exam or ECG abnormalities
- Liver dysfunction exceeding limits unless cancer-related
- Renal impairment below threshold unless cancer-related
- Significant laboratory abnormalities or illnesses posing health risks
- BMI below 18 or above 32 at screening
- Organic brain injury or cognitive impairment
- Positive drug test for non-prescribed substances
- Participation in another investigational drug study within 3 months prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 weeks (Day -45 to Day -2)
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks prior to dosing session
Participants complete three preparation therapy sessions before dosing, including two telehealth sessions and one in-person session in the dosing room, to prepare for psilocybin-assisted psychotherapy.
3 preparation sessions (2 telehealth, 1 in-person)
Duration - One PAP cycle lasting about 10 weeks; up to 2 cycles if needed
Participants receive a single dose of psilocybin-assisted psychotherapy (PAP) under medical supervision on Day 14, followed by an integration therapy session the next day. Non-responders at Week 10 who remain eligible may receive a second PAP cycle with the same schedule.
5 in-person visits (Days 1, 13, 14, 15, and Day 70) plus telehealth visits for preparation, integration, and follow-up
Duration - Up to 3 months post final PAP cycle
Participants continue with telehealth follow-up appointments for safety assessments at Weeks 4, 6, and 3 months after the final PAP cycle to monitor progress and wellbeing.
4 telehealth visits (Weeks 4, 6, Day 70, and 3 months post final cycle)
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
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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