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Subjective Experience Following Psilocybin

Study acronym: SEP-1
StatusRecruiting
PhasePhase 2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Site contact updatedv9
  2. Site contact updatedv8
  3. Recruitment opened
    • Start date changed from estimate of May 2026 to May 15, 2026
    • Site details revised
    v7
  4. Interventions: Placebo (Drug), Psilocybin 1 mg (Drug), Psilocybin 25 mg (Drug), Risperidone 1 MG (Drug) to Placebo (Drug), Psilocybin high-dose (Drug), Psilocybin low-dose (Drug), Risperidone 1 MG (Drug)
    • Eligibility criteria shortened, about 353 words
    • Study description shortened, about 11 words
    v6
  5. Start date: Apr 2026 to May 2026v5
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  1. Start date: Feb 2026 to Apr 2026v4
  2. Enrollment target: 36 to 128v3 Show 8 more changesShow less
    • Start date: Sep 2025 to Feb 2026
    • Primary completion date: Sep 2027 to Dec 2027
    • Study completion date: Oct 2027 to Jan 2028
    • Interventions: Metyrapone 750 mg (Drug), Placebo (Drug), Psilocybin 1 mg (Drug), Psilocybin 25 mg (Drug) to Placebo (Drug), Psilocybin 1 mg (Drug), Psilocybin 25 mg (Drug), Risperidone 1 MG (Drug)
    • Eligibility criteria expanded, about 386 words
    • Secondary endpoints revised (8)
    • Study description shortened, about 9 words
    • Study title revised
  3. Start date: Feb 2025 to Sep 2025
    • Site contact updated
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to determine the importance of the acute subjective experience induced by psilocybin (the primary component of "magic mushrooms") in facilitating positive outcomes. Participants in this study will be given psilocybin in combination with either a placebo or risperidone, an atypical antipsychotic that block the subjective effects of psilocybin.
Trial Details
NCT Number NCT06768944
Lead Sponsor University of Calgary
Conditions
(from sponsor)		 Investigating the Importance of the Subjective Psychedelic Experience
Related terms Fractures, Stress
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov