Adjustment Disorder, Adjustment Disorder With Anxious Mood, Cancer, Cancer Cachexia, Cancer Melanoma Skin, Cancer of Endometrium, Cancer of Kidney, Cancer of Prostate, Cancer of Stomach, Cancer of the Breast, Cancer Pancreas
Conditions
Keywords
Cancer, Adjustment Disorder, Existential Distress, Psilocybin, Psilocin
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.
Detailed description
This is a randomized, double-blind, low-dose comparator-controlled Phase IIb study to investigate the efficacy and safety of PAP with 25 mg, 10 mg and 1 mg \[low-dose comparator) NPX-5, for the treatment of adjustment disorder symptoms in participants diagnosed with cancer. The referring oncologist will indicate that the participant is physically capable of undergoing psychedelic encounter and is likely to have a minimum life expectancy of 6 months. At least 87 adult participants (age 18 to 80 at screening) with a diagnosis of AjD due to cancer diagnosis will be enrolled in this study. Participants will be randomly assigned with a ratio of 1:1:1 to receive Psilocybin-Assisted Psychotherapy (PAP) with either 25 mg, 10 mg or 1 mg NPX-5. Both the site staff treating participants and the participants themselves will be blinded to the treatments being administered. The study consists of a combination of clinic visits and telehealth phone calls to support this vulnerable participant population. The clinic will have experience with conducting PAP. All study visits be carried out by suitably qualified individuals and wherever possible, the same therapist will meet with study participants for in-person and telehealth appointments. Participants will undertake a screening visit between Day -45 and Day -2 to determine eligibility to participate in the study. Those participants that meet the eligibility criteria will attend the study site on Day 1 when continued eligibility will be assessed and baseline assessments performed. Participants must complete three preparation sessions with the therapist prior to dosing session. Two of these sessions can be completed remotely via telehealth and have flexible timing, provided there is at least one day between each session. One preparation session must be done in person in the dosing room, ideally during a site visit on Day 13. Additionally, at least one preparation session must include the sitter or secondary therapist. The primary therapist has the discretion to include the sitter or secondary therapist in more preparation or integration sessions based on their assessment. The clinic site visits will comprise Day 1, Day 13 (day prior dosing session), Day 14 (dosing session), Day 15 (integration session) and Day 70/Week 10 (follow-up) post-randomization. There will be ± 3 days for a dosing session allowed. Subsequently, all relevant visits will be adjusted accordingly. In addition, participants will be required to attend following telehealth appointments: * Two telehealth appointments for preparatory sessions within 2 weeks prior to dosing session. * One telehealth appointment for integration therapy session in the two weeks following the dosing session. * Follow up telehealth appointments on Day 28 (Week 4), Day 42 (Week 6). * Final study follow-up telehealth appointment at 3 months post the Day 70 (Week 10) visit of the final PAP cycle for final safety assessments. Non responders (for criteria see Section 5.5.2) at Day 70 (Week 10) that continue to meet the study eligibility criteria, may commence an additional PAP cycle (at 25 mg NPX-5). These participants will repeat the schedule described above, including the visit the day prior to dosing session, the actual dosing session, and the integration sessions. A maximum of 2 PAP cycles may be administered.
Interventions
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.
Sponsors
Psyence Australia Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for study entry participants must satisfy all of the following criteria: 1. Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer. 2. Screening HAM-A Score ≥18 (moderate anxiety). 3. Adults aged 18 to 80 years (inclusive) at screening. 4. Diagnosed with cancer (exempting those cancers listed in the
Exclusion criteria
) 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. 5. Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10. 6. 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. 7. Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist. 8. 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. 9. Have access to a device that is compatible to use the digital technology, i.e smart-phone device or tablet. 10. 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. 11. 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. 12. 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). 13. 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 clinical judgement and with sufficient justification provided.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Number of participants with treatment-related adverse events as assessed by CTCAE V5.0 | Assessment of Day 14 (dosing day) vital signs (pre-dose and prior to discharge). | 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. |
| Safety and Tolerability of a Single Dose of NPX-5 using the Sheehan Suicide Tracking Scale (S-STS) | 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. | 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. |
Countries
Australia
Contacts
CONTACTTim Waugh
STUDY_DIRECTORClive Ward-Able
Psyence Biomedical
Outcome results
None listed