University of Wisconsin, Madison
This study will examine whether combining a single dose of psilocybin with non-invasive transauricular vagus nerve stimulation (taVNS), a known inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS 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.
Healthy
Psychedelic Experiences
Vagus Nerve Stimulation
Psilocybin
Transauricular Vagus Nerve Stimulation (taVNS)
Sham taVNS
Treatment as Usual (TAU)
Phase 1
One hundred and eight adults will receive a single open-label 25 mg dose of psilocybin administered within a "set and setting" (SaS) framework of psychological support provided by trained facilitators, such as has been successfully employed in prior psychedelic studies at University of Wisconsin-Madison. The SaS protocol will include 2-4 hours of preparation, a 6- to 8-hour psilocybin dosing session and an hour-long integration session 1 day and 9 days post dosing. All subjects will receive various combinations of active taVNS or sham taVNS prior to, or following, psilocybin dosing. Active and sham taVNS sessions will last 20 minutes and will occur twice daily (morning and afternoon/evening) for 7 consecutive days, using an "at home" protocol that has been used safely and effectively by study collaborators. taVNS is a non-invasive low-risk procedure. Subjects will be randomized with equal allocation to one of four conditions: 1) seven days of sham taVNS prior to psilocybin dosing and 7 days of active taVNS post- psilocybin dosing (Group 1: n=27); 2) seven days of sham taVNS prior to psilocybin dosing and 7 days of sham taVNS post- psilocybin dosing (Group 2: n=27); 3) seven days of sham taVNS prior to psilocybin dosing and treatment as usual post- psilocybin dosing (Group 3: n=27); and 4) seven days of active taVNS prior to psilocybin dosing and 7 days of sham taVNS post- psilocybin dosing (Group 4: n=27). It is anticipated that a total sample of 108 subjects will be enrolled to provide 100 subjects who complete study activities/assessments sufficient to provide evaluable data for testing study primary and exploratory outcomes.}}
Study Type : | Interventional |
Estimated Enrollment : | 108 participants |
Masking : | Triple |
Primary Purpose : | Basic Science |
Official Title : | Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin |
Actual Study Start Date : | August 2024 |
Estimated Primary Completion Date : | July 2027 |
Estimated Study Completion Date : | October 2027 |
Arm | Intervention/treatment |
---|---|
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. |
Drug: Psilocybin Device: Transauricular Vagus Nerve Stimulation (taVNS) |
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. |
Device: Sham taVNS Drug: Psilocybin |
Active Comparator: Group 3: Sham taVNS + Psilocybin + Treatment as Usual Group 3 will receive twice daily sham taVNS for 7 days immediately prior to psilocybin dosing. Post-psilocybin dosing, they will receive treatment as usual (TAU), comprised of an integration session 1 day and 1-week post-psilocybin dosing. |
Device: Sham taVNS Drug: 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. |
Device: Sham taVNS Behavioral: Treatment as Usual (TAU) |
Ages Eligible for Study: | 18 Years to 70 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
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Not yet recruiting
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53715