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Clinical Trial Summary

The goal of this clinical trial is to test whether transauricular vagus nerve stimulation (taVNS) can enhance the long-term positive emotional meaningfulness of the psychedelic experience. Medically-healthy participants will receive a single 25 mg dose of psilocybin followed by 1) taVNS treatment, 2) taVNS sham treatment, or 3) treatment as usual, depending on group assignment. All participants will complete a screening visit to determine eligibility, two baseline visits, a dosing visit, and three follow-up visits. taVNS or sham taVNS will be completed at home and monitored remotely by study personnel. This study will contribute to the field of psychedelic medicine by studying ways to enhance and extend the therapeutic effects of psychedelics.

Clinical Trial Description

100 participants will receive an open label treatment with a single 25 mg dose of psilocybin and will be randomized with equal allocation to one of four groups. Group 1 will receive twice-daily transauricular vagus nerve stimulation (taVNS) paired with psychedelic session contextual cues for 7 days immediately post-psilocybin dosing. Group 2 will receive twice-daily sham taVNS paired with psychedelic session contextual cues for 7 days immediately post-psilocybin dosing. Group 3 will receive treatment as usual (TAU) post dosing, comprised of an integration session 1 day and 1-week post-psilocybin dosing. To address the possibility that taVNS will have direct effects on wellbeing and other relevant outcomes, Group 4 will receive twice daily taVNS for 7 days immediately prior to psilocybin dosing, and Groups 1-3 will undergo the same regimen prior to psilocybin dosing but will receive sham taVNS. Primary hypothesis-driven study endpoints will be tested in randomized groups 1-3 (taVNS vs. sham taVNS vs. TAU delivered post-psilocybin dosing). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05866471
Study type Interventional
Source University of Wisconsin, Madison
Contact Project Manager
Phone 608-921-7823
Status Not yet recruiting
Phase Phase 1
Start date September 2023
Completion date September 2026

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