Pairing Psilocybin With Transauricular Vagus Nerve Stimulation (ENHANCE)

This Phase I interventional trial (n=100), conducted by the University of Wisconsin, Madison, in collaboration with the Tiny Blue Dot Foundation, aims to investigate whether transauricular vagus nerve stimulation (taVNS) can enhance the long-term positive emotional meaningfulness of psilocybin (25mg) experiences.

The study involves 100 medically healthy participants receiving a single 25 mg dose of psilocybin, followed by either taVNS treatment, sham taVNS, or treatment as usual, depending on group assignment. The participants will be assessed using measures such as the Memory Experiences Questionnaire, functional magnetic resonance imaging (fMRI), and the Warwick-Edinburgh Mental Wellbeing Scale. The primary completion is estimated for March 2027, with enrollment starting in March 2024.

For additional details, the Project Manager can be contacted at the University of Wisconsin – Madison, and the study is expected to contribute valuable insights to the field of psychedelic medicine. The trial is designed as a randomized, triple-masked, factorial assignment with various intervention arms, including different combinations of taVNS, sham taVNS, and treatment as usual. The intervention involves the administration of psilocybin, and the study will assess outcomes related to autobiographical memory, brain activation, and mental wellbeing over an eight-week period.

The study is set to commence in March 2024 and is expected to be completed in March 2027, with an estimated enrollment of 100 participants. Participants should be between 18 to 65 years old, and the trial is open to both sexes, accepting healthy volunteers.

The study’s primary investigator is Dr. Charles Raison, and the sponsor is the University of Wisconsin, Madison, in collaboration with the Tiny Blue Dot Foundation. The study’s publications and results will be shared in accordance with the IPD (Individual Participant Data) sharing plan, with data available to qualified researchers following the publication of primary study findings.

Trial Details

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.

NCT Number NCT05866471

Data attribution

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