The ENHANCE Study: taVNS and Psilocybin

Study acronym: ENHANCE
StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Enrollment target: 108 to 115
    • Eligibility criteria expanded, about 18 words
  2. Collaborators: 1 to 2v22
  3. Study Status, Referencesv21
  4. Eligibility criteria expanded, about 6 wordsv20
  5. Primary endpoints revised (4)
    • Eligibility criteria expanded, about 3 words
    v19
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  1. Re-verified, no change to tracked fieldsv18
  2. Eligibility criteria expanded, about 12 wordsv17
  3. Start date changed from estimate of Feb 2025 to Jan 27, 2025v16
  4. Re-verified, no change to tracked fieldsv15
  5. Start date: Jan 2025 to Feb 2025
    • Site contact updated
    v14
  6. Start date: Nov 2024 to Jan 2025
    • Primary completion date: Sep 2027 to Nov 2027
    • Study completion date: Dec 2027 to Jan 2028
    v13
  7. Site contact updated
    • Study title shortened, about 2 words
    v12
  8. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v11
  9. Start date: Oct 2024 to Nov 2024v10 Show 4 more changesShow less
    • Interventions: Psilocybin (Drug), Sham taVNS (Device), Transcutaneous auricular Vagus Nerve Stimulation (taVNS) (Device), Treatment as Usual (TAU)… to Psilocybin (Drug), Psychosocial Support Alone (Behavioral), Sham taVNS (Other), Transcutaneous auricular Vagus Nerve Stimulation (taVNS)…
    • Eligibility criteria revised
    • Study description expanded, about 58 words
    • Site contact updated
  10. Start date: Aug 2024 to Oct 2024
    • Primary completion date: Jul 2027 to Sep 2027
    • Study completion date: Oct 2027 to Dec 2027
    v9
  11. Primary endpoints: 3 to 4
    • Interventions: Psilocybin (Drug), Sham taVNS (Device), Transauricular Vagus Nerve Stimulation (taVNS) (Device), Treatment as Usual (TAU) (Behavioral) to Psilocybin (Drug), Sham taVNS (Device), Transcutaneous auricular Vagus Nerve Stimulation (taVNS) (Device), Treatment as Usual (TAU)…
    • Study title expanded, about 1 word
    v8
  12. Re-verified, no change to tracked fieldsv7
  13. Start date: Mar 2024 to Aug 2024v6 Show 6 more changesShow less
    • Primary endpoints revised (3)
    • Enrollment target: 100 to 108
    • Primary completion date: Mar 2027 to Jul 2027
    • Study completion date: Mar 2027 to Oct 2027
    • Eligibility criteria expanded, about 60 words
    • Study description expanded, about 106 words
  14. Re-verified, no change to tracked fieldsv5
  15. Site contact updatedv4
  16. Start date: Sep 2023 to Mar 2024
    • Primary and study completion dates: Sep 2026 to Mar 2027
    v3
  17. Site contact updatedv2
  1. Study First Submitted
  • 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.
This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a potential inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS or no VNS by allowing memory for insights gained during the psychedelic experience to remain vivid after they will have faded in subjects who receive psilocybin followed by sham taVNS or no VNS.
Trial Details
NCT Number NCT05866471
Lead Sponsor University of Wisconsin, Madison
Collaborators: Tiny Blue Dot Foundation, Advanced Research Projects Agency for Health (ARPA-H)
Conditions
(from sponsor)		 Healthy, Psychedelic Experiences, Vagus Nerve Stimulation
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov