Health TrialsbyHealthPanel

The ENHANCE Study: taVNS and Psilocybin

ConditionsHealthyPsychedelic ExperiencesVagus Nerve Stimulation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

English speaking

Ability/willingness to complete all study activities

Modest reduction in emotional well-being

Medically healthy (does not meet criteria for an exclusionary medical condition)

Disqualifiers

Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)

Current or clinically significant psychiatric disorder that, in the investigator's judgment, would interfere with participation or increase risk

Current use of drugs or medications, prescribed or otherwise, that may interact with psilocybin

Use of investigational drugs, biologics, or devices within 30 days of enrollment

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

108 Participants
are divided into 4 treatment groups
Group A: Group 1: Sham taVNS + Psilocybin + taVNSExperimental treatment 3 interventions
Group B: Group 2: Sham taVNS + Psilocybin + Sham taVNSSham comparator 2 interventions
Group C: Group 3: Sham taVNS + Psilocybin + Psychosocial Support AloneActive comparator 3 interventions
Group D: Group 4: taVNS + Psilocybin + Sham taVNSActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Memory Experiences Questionnaire (MEM-Q-PSIL): Comparison of taVNS Administration vs. Treatment as Usual

The MEM-Q is 31-item self-report scales designed to measure 10 phenomenological qualities of autobiographical memories: Vividness, Coherence, Accessibility, Time Perspective, Sensory Details, Visual Perspective, Emotional Intensity, Sharing, Distancing and Valence. Ratings are made on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).

Time frame
8 weeks
2

Functional Magnetic Resonance Imaging (fMRI): Comparison of taVNS Administration vs. Treatment as Usual

Activation in brain regions associated with cued autobiographical memory retrieval will be assessed with fMRI. Group comparisons will examine differences in whole brain blood oxygenated level dependent (BOLD) signal and connectivity based on previously established seed-based methods using a priori brain regions implicated in autobiographical memory retrieval corresponding dosing session stimuli. The study team will update with more specific information when the details are confirmed.

Time frame
Day 1 and Day 56 Post- Psilocybin Dose
3

Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Comparison of taVNS Administration vs. Treatment as Usual

The WEMWBS is a 14-item self-report scale that was designed to measure the psychological well-being of a population. The questions use a five-point Likert scale. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing. Items on the questionnaire are rated on a 5-point scale, where 1= "None of the time", 2= "rarely", 3= "some of the time", 4= "often", 5= "all the time". A total scale score is calculated by summing the 14 individual item scores. The total possible range of scores for the WEMWBS is 14-70 with higher scores indicating a greater well-being.

Time frame
8 weeks
4

Summary of Adverse Events

Adverse events (AEs) categorized by CTCAE v5.0 criteria at all assessments (6 study visits).

Time frame
up to 8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Tiny Blue Dot Foundation

Collaborator

Advanced Research Projects Agency for Health (ARPA-H)

Collaborator

Source ClinicalTrials.gov
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