Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder

NCT07072728 | Recruiting Phase 2

• 1 other identifier: PSY-01
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Cancer; Adjustment Disorder; Existential Distress; Psilocybin; Psilocin

Outcome Measures

Primary Outcomes (3)

• Anxiety Severity

  To assess the change in anxiety severity in participants with Adjustment Disorder (AjD) due to a cancer diagnosis, as measured by the Hamilton Anxiety Rating Scale (HAM-A). The Hamilton Anxiety Rating Scale (HAM-A) ranges from 0 to 56, with higher scores indicating greater anxiety severity.

  Comparison between treatment groups in the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score at Week 10 after a single PAP cycle.

• Number of participants with treatment-related adverse events as assessed by CTCAE V5.0

  To assess the safety and tolerability of a single dose of NPX-5 (25 mg, 10 mg and 1 mg \[low-dose comparator\]) in people with AjD with a cancer diagnosis.

  Assessment of Day 14 (dosing day) vital signs (pre-dose and prior to discharge).

• Safety and Tolerability of a Single Dose of NPX-5 using the Sheehan Suicide Tracking Scale (S-STS)

  To assess the safety and tolerability of a single dose of NPX-5 (25 mg, 10 mg, and 1 mg \[low-dose comparator\]) in people with Adjustment Disorder (AjD) due to a cancer diagnosis, using the Sheehan Suicide Tracking Scale (S-STS). The Sheehan Suicide Tracking Scale (S-STS) is a clinician-rated measure of suicidality that assesses suicidal ideation and behaviour. The scale consists of 14 items, with scores ranging from 0 to 60, where higher scores indicate greater suicidality risk.

  Assessment of suicidality using the Sheehan Suicide Tracking Scale (S-STS) at baseline, Day 13, Day 15, Weeks 4, 6, and 10, and 3 months post-final cycle.

Study Arms (3)

Group 1: 25 mg NPX-5 Psilocybin Capsules

ACTIVE COMPARATOR

Participants in Group 1 will receive a single dose of 25 mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the same 25 mg dose. A maximum of two PAP cycles may be administered.

Drug: Psilocybin therapy

Group 2: 10 mg NPX-5 Psilocybin Capsules

ACTIVE COMPARATOR

Participants in Group 2 will receive a single dose of 10mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the 25 mg dose. A maximum of two PAP cycles may be administered.

Drug: Psilocybin therapy

Group 3: 1 mg NPX-5 (low-dose comparator)

PLACEBO COMPARATOR

Participants in Group 3 will receive a single dose of 1mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the same 25 mg dose. A maximum of two PAP cycles may be administered.

Drug: Psilocybin therapy

Interventions

Psilocybin therapy DRUG

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.

Group 1: 25 mg NPX-5 Psilocybin Capsules; Group 2: 10 mg NPX-5 Psilocybin Capsules; Group 3: 1 mg NPX-5 (low-dose comparator)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Must be willing and able to refrain from smoking throughout the duration of the dosing session. Nicotine replacement therapies may be permitted with the agreement of the medical monitor.
• Agree that for 1 week before the psilocybin dosing session, participants will refrain from taking any illegal drugs or non-prescription medication (including cannabis, or CBD or THC containing products), nutritional supplement, or herbal supplement except when approved by the study investigators. Additionally, agree not to take any form of psilocybin outside of the study, including microdosing, from baseline through Day 70/Week 10 (Visit 11).
• Participants will be excluded from the study if one or more of the following criteria are applicable:
• Current Major Depressive Disorder MDD (or within 12 months of Screening) deemed independent from the cancer diagnosis, current or past diagnosis of schizophrenia, psychotic disorder, unless this was resulting from a medical condition (e.g. lupus or malaria etc.), bipolar disorder I and II, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anti-social personality disorder or judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as determined using clinical judgement of past and present medical and psychiatric history by any specialist psychiatrist or registered medical professional under the authorized delegation of a specialist psychiatrist.
• First-degree relative with a diagnosed psychotic disorder.
• Scores from the screening psychiatrist (or registered medical professional under the authorized delegation of a specialist psychiatrist) and baseline (S-STS) that indicate that the participant is of clinically significant risk of suicide. A decision will be formed based on S-STS scores and used in combination with other clinically significant data at screening. Sites should refer to the medical monitor if required.
• Has attempted suicide in the twelve months preceding the screening visit.
• Current (\< 1 year) alcohol or drug misuse as identified as moderate or severe during screening in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, using the MINI 7.0.2, not able or willing to abstain from alcohol consumption in the period 12 hours prior to the dosing session.
• Any other reason that might prevent a participant from engaging in therapeutic preparation and integration sessions.

Sponsors & Collaborators

• Psyence Australia Pty Ltd: lead

Study Sites (3)

Mind Medicine Australia Clinic

Abbotsford, Victoria, 3067, Australia

RECRUITING

Paratus Clinical Research Melbourne

Northcote, Victoria, 3070, Australia

RECRUITING

Empax Centre

Leederville, Western Australia, 6007, Australia

RECRUITING

MeSH Terms

Conditions

Adjustment Disorders; Neoplasms; Endometrial Neoplasms; Kidney Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Stomach Neoplasms; Melanoma; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Clive Ward-Able

  Psyence Biomedical

  STUDY DIRECTOR

Central Study Contacts

Tim Waugh

CONTACT

+61481354373; tim@psyencebiomed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be centrally randomized 1:1:1 to a treatment group. * Group 1: 25 mg NPX-5; * Group 2: 10 mg NPX-5; * Group 3: 1 mg NPX-5(low-dose comparator).

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: July 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)