Clinical TrialPalliative & End-of-Life DistressPsilocybinRecruiting

PARTING: Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief

This single-arm, open-label trial (n=15) assesses feasibility, acceptability and safety of psilocybin-assisted supportive psychotherapy (single 25 mg oral psilocybin session) for prolonged grief disorder in bereaved cancer carers.

Target Enrollment
15 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Single-group, open-label Phase I feasibility study delivering manualised supportive psychotherapy around a single 25 mg oral psilocybin dosing session to bereaved carers with prolonged grief disorder; psychotherapy includes three preparatory sessions and four integration sessions delivered by a lead clinical psychologist and an assistant therapist with psychiatrist oversight.

Primary outcomes are feasibility metrics (recruitment, retention, and fidelity) measured via REDCap logs and session recordings; clinical measures of grief (PG-13-Revised) and other follow-up questionnaires are assessed at baseline, 1 day, 6 weeks, 12 weeks, 6 months and 12 months post dosing.

Study Protocol

Preparation

3 sessions
90 min each

Dosing

1 sessions
480 min each

Integration

4 sessions
90 min each

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin + therapy

experimental

Single-group psilocybin-assisted supportive psychotherapy: one 25 mg oral psilocybin dosing session with pre- and post-therapy sessions.

Interventions

  • Psilocybin25 mg
    via Oral• single dose

    Psilocybin trihydrate 25 mg capsule provided by Cortexa; administered with water during an ~8-hour dosing session.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Adult bereaved carer of a patient who died from cancer more than 12 months ago
  • Meets threshold for prolonged grief disorder on the PG-13-Revised and clinical interview
  • Under the care of a psychiatrist, psychologist, physician, or general practitioner
  • Proficient in English with sufficient literacy/comprehension for consent and questionnaires
  • Living in Brisbane QLD or able to travel to Brisbane for in-person sessions
  • Intention to complete all 8 intervention sessions
  • Agree to have dosing sessions video-recorded for fidelity and supervision
  • Able to swallow pills
  • Treating doctor can confirm safe taper and washout of current antidepressant pharmacotherapy prior to baseline
  • Agree to abstain from illicit drugs and alcohol and from disallowed medications for at least 2 days prior to psilocybin dosing

Exclusion Criteria

  • Disorder with known central nervous system involvement
  • Currently in another clinical trial involving an investigational product
  • Hepatic dysfunction
  • Hypercalcaemia, Cushing's syndrome, hypoglycaemia, SIADH, or carcinoid syndrome
  • Cardiovascular conditions (clinically significant)
  • Currently on preventative medication for migraines
  • Epilepsy
  • Positive pregnancy test or trying to get pregnant
  • Current hypothyroidism or hyperthyroidism as identified by blood test
  • Weight less than 40 kg or BMI <15
  • Use of any hallucinogen or psychedelic drug within the past 12 months
  • Significant adverse events after prior use of any hallucinogen or psychedelic
  • Medications that may interact with psilocybin
  • Diagnosed psychotic disorder or severe PTSD
  • First-degree family member with a diagnosed psychotic disorder
  • History of suicide attempts or mania
  • Moderate–severe drug or alcohol dependence
  • Unable to give adequate informed consent

Study Details

Locations

Unknown facility — Australia

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