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Psychedelic

Psilocybin + taVNS for Enhancing Psychedelic Experiences (ENHANCE Trial)

Phase 1
Waitlist Available
Led By Charles Raison, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 56 post- psilocybin dose

Summary

This trial is testing if combining psilocybin with a gentle nerve stimulation technique can make the positive effects of psilocybin last longer. The study involves adults who will receive a dose of psilocybin and either real or fake nerve stimulation. The goal is to see if the nerve stimulation helps keep the memories from the psilocybin experience vivid and beneficial.

Who is the study for?
This trial is for English-speaking, medically healthy individuals who can swallow pills and agree to use contraception if they are sexually active. They should have a slight decrease in emotional well-being but no current serious medical conditions, psychiatric diagnoses, abnormal lab results, heart issues like hypertension or tachycardia, and not be pregnant or breastfeeding.
What is being tested?
The study tests if transauricular vagus nerve stimulation (taVNS) can make the positive effects of psilocybin last longer. Participants will take a single dose of psilocybin and then receive either real taVNS treatment, sham taVNS treatment without actual stimulation, or usual care with no additional intervention.
What are the potential side effects?
Psilocybin may cause changes in perception, mood swings, nausea, headache or increased heart rate. The taVNS could potentially lead to mild discomfort at the site of application. Side effects vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 56 post- psilocybin dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 56 post- psilocybin dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Functional Magnetic Resonance Imaging (fMRI): Comparison of taVNS Administration vs. Treatment as Usual
Memory Experiences Questionnaire (MEM-Q): Comparison of taVNS Administration vs. Treatment as Usual
Summary of Adverse Events
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Group 1: Sham taVNS + Psilocybin + taVNSExperimental Treatment3 Interventions
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.
Group II: Group 4: taVNS + Psilocybin + Sham taVNSActive Control3 Interventions
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.
Group III: Group 3: Sham taVNS + Psilocybin + Treatment as UsualActive Control3 Interventions
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.
Group IV: Group 2: Sham taVNS + Psilocybin + Sham taVNSPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~750
Sham taVNS
2021
N/A
~60

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Psilocybin induces psychological insights by acting on serotonin receptors, particularly the 5-HT2A receptor, leading to altered perception and cognition. Transcutaneous auricular vagus nerve stimulation (taVNS) enhances neuroplasticity and memory formation by stimulating the vagus nerve. Combining these treatments could amplify the beneficial effects of psilocybin, making psychological insights more vivid and long-lasting. This is significant for healthy subjects as it may improve cognitive function, emotional well-being, and overall mental health.
Role of the 5-HT<sub>2A</sub> Receptor in Self- and Other-Initiated Social Interaction in Lysergic Acid Diethylamide-Induced States: A Pharmacological fMRI Study.Chocolate and the brain: neurobiological impact of cocoa flavanols on cognition and behavior.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Tiny Blue Dot FoundationOTHER
9 Previous Clinical Trials
550 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,223 Previous Clinical Trials
3,168,043 Total Patients Enrolled
Charles Raison, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
16 Previous Clinical Trials
833 Total Patients Enrolled

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05866471 — Phase 1
Healthy Subjects Research Study Groups: Group 1: Sham taVNS + Psilocybin + taVNS, Group 4: taVNS + Psilocybin + Sham taVNS, Group 2: Sham taVNS + Psilocybin + Sham taVNS, Group 3: Sham taVNS + Psilocybin + Treatment as Usual
Healthy Subjects Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05866471 — Phase 1
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05866471 — Phase 1
~72 spots leftby Sep 2027