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New treatment option for Adjustment Disorder
Official title Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
ClinicalTrials.gov ID: NCT07072728
What this study is testing
What is Psilocybin therapy?
Psilocybin therapy is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for adjustment disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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.
- Diagnosed with cancer (exempting those cancers listed in the
You likely can't join if
- ) 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...
- 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...
- 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...
- Have access to a device that is compatible to use the digital technology, i.e smart-phone device or tablet.
See the full eligibility criteria
Who can join
- 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
What rules you out
- ) 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...
- 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...
- Participants taking any other medication that is not explicitly detailed as an excluded medication will be discussed with the investigator and medical monitor as appropriate. Decisions on inclusion will be based on...
- 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...
- 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...
- 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...
- Any other reason that might prevent a participant from engaging in therapeutic preparation and integration sessions.
- Anyone who has taken a microdose of psilocybin within 5 days of baseline, taken a higher dose of psilocybin (e.g., dried mushrooms or capsules) within 30 days of baseline and experienced euphoria, hallucinations, or...
- Diagnosed with brain metastases, glioblastoma, phaeochromocytoma, bowel obstruction or intestinal failure, active carcinoid syndrome, uncontrolled hypercalcaemia, or uncontrolled diabetes mellitus or insipidus.
- Currently taking or planning to take any of the following: any typical or atypical antipsychotic and monoamine-oxidase inhibitors. Participants with prior use of these medications must be willing to discontinue their...
- Currently taking or planning to take any anticonvulsant or mood stabilizer, including carbamazepine, lithium, phenytoin, and valproate. Participants with prior use of these medications must be willing to discontinue...
- Any form of fungal allergy.
- Positive pregnancy test at screening, women who are breastfeeding or of childbearing potential who are unwilling or unable to use an effective form of contraception (or abstinence) for the study period and for 1 month...
- A diagnosis of epilepsy or at significant risk of seizures based on medical history.
- Cardiovascular conditions including stroke and/or myocardial infarction (less than one year before providing informed consent), uncontrolled hypertension (blood pressure \> 140/90 mmHg) or clinically significant...
- Anyone who, at screening, has clinically significant findings on physical examination, including resting vital signs (HR below 40 or above 120 bpm, blood pressure below 90/60 or above 140/90), ECG (QTcF \> 450 msec for...
- Liver dysfunction at screening as defined by AST and/or ALT \> 1.5 times the upper level of normal or upper reference range. Results are exempt if they are a direct result of the participant's cancer diagnosis and do...
- Renal Function: estimated glomerular filtration rate \<60 mL/min (calculated using Chronic Kidney Disease Epidemiology Collaboration) unless this is a direct result of the cancer diagnosis and does not present a risk to...
- Any clinically significant laboratory abnormality(s) that in the opinion of the investigator would present a risk to the administration of psilocybin.
- Any clinically significant renal, pulmonary, gastrointestinal, hepatic, or other illness that could affect the interpretation of results or be a potential health risk for the person if they were to be included in the...
- Below 18 or above 32kg/m2 Body Mass Index (BMI) score at Screening.
- Anyone with organic brain injury or diagnosed with any cognitive impairment.
- Positive urine drug test for non-prescribed psychoactive substances at the dosing session visit. Positive urine drug test for psychoactive substances at the in-person screening should be referred to the medical monitor...
- Anyone on a research study of an investigational drug or who has been on a clinical trial within 3 months of enrolment.
The study team makes the final eligibility decision.
Where it's taking place
- Abbotsford, Victoria, Australia
- Northcote, Victoria, Australia
- Leederville, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Abbotsford, Victoria, Australia; Northcote, Victoria, Australia; Leederville, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.