Clinical TrialPalliative & End-of-Life DistressPsilocybinPlaceboActive not recruiting

Psilocybin-assisted psychotherapy for the treatment of depression and anxiety associated with life-threatening illness

This parallel-group, double-blinded, randomised controlled trial (n=35) investigates a single 25 mg oral psilocybin dose plus structured psychotherapy versus active placebo (100 mg niacin) for depression and anxiety in terminally ill patients.

Target Enrollment
35 participants
Study Type
Phase II interventional
Design
Randomized, single Blind

Detailed Description

Parallel-group, randomised, double-blinded RCT (part 1) followed by an open-label phase (part 2); participants receive either 25 mg psilocybin or 100 mg niacin in the RCT, then all receive open-label psilocybin for the second dose.

Psychotherapy is provided before, during and after dose sessions: 11 sessions in total including two dose days, with preparatory sessions (3 before dose 1), integrative/preparatory sessions (3 between dose 1 and dose 2), and integrative sessions after dose 2. Sessions last up to 2 hours; dose days up to 8 hours.

Outcomes include changes in depression and anxiety (HADS), death anxiety (DAP-R), quality of life, spiritual wellbeing, demoralisation, and qualitative interview data; follow-up continues to 26 weeks post dose two.

Study Protocol

Preparation

3 sessions
120 min each

Dosing

2 sessions
480 min each

Integration

6 sessions
120 min each

Therapeutic Protocol

existential humanistic

Study Arms & Interventions

Psilocybin 25 mg

experimental

Single supervised oral psilocybin dose (25 mg) given with preparatory and integrative psychotherapy.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Single supervised oral capsule; drug packaging returned

Niacin 100 mg (active placebo)

active

Single supervised oral niacin dose as active placebo during RCT phase.

Interventions

  • Placebo100 mg
    via Oral• single dose• 1 doses total

    Active placebo to produce flushing response

Participants

Ages
18 – 85
Sexes
Male & Female

Inclusion Criteria

  • Adults aged between 18-85 years with a life-threatening illness, under the care of a specialist physician; proficient in English; experiencing psychological distress precipitated or augmented by their life-threatening illness; AKPS of 50 or above (or if immobile but deemed physically well enough to participate by study doctor and treating physician, scores lower than 50) upon receipt of medical clearance from primary treating physician and screening by study doctor.

Exclusion Criteria

  • Diseases with major CNS involvement; hepatic dysfunction; known paraneoplastic syndrome or ectopic hormone production; uncontrolled cardiovascular conditions (including unstable angina, atrial fibrillation, TIA); patients who are respirator dependent or intubated; diagnosis of epilepsy or known previous seizure activity; renal insufficiency; insulin-dependent diabetes; females who are pregnant, nursing, or attempting to become pregnant; patients taking SSRI or SNRI (may be eligible if weaned and ceased under supervision and deemed safe); participants taking interacting medications (rifamycin, rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, paclitaxel, St John's Wort, HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin); psychiatric exclusions: severity of depression or anxiety warranting immediate hospitalisation (including acute suicidality); current or past history of psychosis/psychotic disorder; current or past history of bipolar disorder; first-degree relative with psychosis or bipolar disorder; current or past history of alcohol or substance dependence in past 5 years; Axis II conditions incompatible with protocol (determined by clinical interview).

Study Details

Locations

Unknown facility — Australia

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