The ENHANCE Study: taVNS and Psilocybin

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT05866471
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy
  • Psychedelic Experiences
  • Vagus Nerve Stimulation

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Psilocybin — DRUG
    The psilocybin is produced under Good Manufacturing Practice and is in a capsule that contains 25 mg of botanically-derived psilocybin.
  • Transcutaneous auricular Vagus Nerve Stimulation (taVNS) — DEVICE
    For both the active and sham taVNS procedure, participants will be provided with, and trained on, taVNS devices that apply gentle stimulation to the left ear via either electrodes or an earpiece that fits over the left ear.
  • Psychosocial Support Alone — BEHAVIORAL
    Participants assigned to Psychosocial Support Alone will not receive taVNS following psilocybin dosing.
  • Sham taVNS — OTHER
    For both the active and sham taVNS procedure, participants will be provided with, and trained on, taVNS devices that apply gentle stimulation to the left ear via either electrodes or an earpiece that fits over the left ear.

Study Details

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.

Key Dates

Start date
Jan 27, 2025
Status verified
Mar 2026
Primary completion
Nov 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1: Sham taVNS + Psilocybin + taVNS
    Group 1 will receive twice daily sham taVNS for 7 days immediately prior to psilocybin dosing. Post-psilocybin dosing, they will receive twice-daily taVNS paired with psychedelic session contextual cues for 7 days.
  • Sham Comparator: Group 2: Sham taVNS + Psilocybin + Sham taVNS
    Group 2 will receive twice daily sham taVNS for 7 days immediately prior to psilocybin dosing. Post-psilocybin dosing, they will receive twice-daily sham taVNS paired with psychedelic session contextual cues for 7 days.
  • Active Comparator: Group 3: Sham taVNS + Psilocybin + Psychosocial Support Alone
    Group 3 will receive twice daily sham taVNS for 7 days immediately prior to psilocybin dosing. Post-psilocybin dosing, they will receive psychosocial support alone, comprised of an integration session 1 day and 1-week post-psilocybin dosing. They will not receive active or sham taVNS post-psilocybin.
  • Active Comparator: Group 4: taVNS + Psilocybin + Sham taVNS
    Group 4 will receive twice daily taVNS for 7 days immediately prior to psilocybin dosing. Post-psilocybin dosing, they will receive twice-daily sham taVNS paired with psychedelic session contextual cues for 7 days.

Primary Outcome Measure

Memory Experiences Questionnaire (MEM-Q-PSIL): Comparison of taVNS Administration vs. Treatment as Usual [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin - MadisonMadisonWisconsin53715
Program Manager
[email protected]
Christopher Nicholas, PhD (SUB_INVESTIGATOR)

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University of Wisconsin - Madison· Madison, WI

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