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NCT07072728

Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved 3 months later.

See at-risk trials from Psyence Australia Pty Ltd

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 30, 2026 to Mar 30, 2027 Show 4 more changesShow less
    • Study completion pushed from Jul 30, 2027 to Dec 30, 2027
    • Study sites: 3 to 5
    • Eligibility criteria expanded, about 36 words
    • Study description expanded, about 4 words
  2. Primary completion date: May 21, 2026 to Dec 30, 2026v4 Show 6 more changesShow less
    • Primary endpoints revised (3)
    • Study completion date: Aug 21, 2026 to Jul 30, 2027
    • Start date changed from estimate of Sep 15, 2025 to Oct 1, 2025
    • Study description revised
    • Site details revised at 1 of 3 sites
    • Eligibility criteria expanded, about 1 word
  3. Study sites: 2 to 3
    • Start date: Aug 21, 2025 to Sep 15, 2025
    v3
  4. Start date: Jul 21, 2025 to Aug 21, 2025
    • Study sites: 1 to 2
    v2
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Anxiety Severity
Timeframe: 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.
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0
Timeframe: Assessment of Day 14 (dosing day) vital signs (pre-dose and prior to discharge).
Safety and Tolerability of a Single Dose of NPX-5 using the Sheehan Suicide Tracking Scale (S-STS)
Timeframe: 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.

Arms and interventions

Group 1: 25 mg NPX-5 Psilocybin CapsulesActive comparator

Participants in Group 1 will receive a single dose of 25 mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the same 25 mg dose. A maximum of two PAP cycles may be administered.

Group 2: 10 mg NPX-5 Psilocybin CapsulesActive comparator

Participants in Group 2 will receive a single dose of 10mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the 25 mg dose. A maximum of two PAP cycles may be administered.

Group 3: 1 mg NPX-5 (low-dose comparator)Placebo comparator

Participants in Group 3 will receive a single dose of 1mg NPX-5 psilocybin capsules under medical supervision on Day 14. Non-responders at Week 10, who continue to meet eligibility criteria, may receive a second cycle of psilocybin-assisted psychotherapy (PAP) at the same 25 mg dose. A maximum of two PAP cycles may be administered.

Drugs: Psilocybin therapy

Sites

5 sites in 1 country