Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder

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 wil

Trial Details

NCT ID
NCT07072728
Phase
PHASE2
Sponsor
Psyence Australia Pty Ltd
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Psilocybin therapy
Locations (sample)
  • Abbotsford, Victoria, Australia|-37.8,145
  • Northcote, Victoria, Australia|-37.76667,145
  • Leederville, Western Australia, Australia|-31.93628,115.8419

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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