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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
Awards & highlights
ENHANCE Trial Summary
This trial tests if taVNS can enhance the long-term positive effects of psychedelics. Participants receive psilocybin, taVNS, sham taVNS, or a placebo & complete screening & follow-up visits. Results will contribute to psychedelic medicine.
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.Check my eligibility
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.See study design
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.
ENHANCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 and day 56 post- psilocybin dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 56 post- psilocybin dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Comparison of taVNS Administration vs. Treatment as Usual
ENHANCE 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
~730
Sham taVNS
2021
N/A
~60
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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 FoundationUNKNOWN
4 Previous Clinical Trials
283 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,279 Total Patients Enrolled
Charles Raison, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
15 Previous Clinical Trials
684 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow all study requirements.I am generally in good health with no major medical conditions.I can take pills by mouth.I do not have any severe illnesses that would exclude me from the trial.I am taking medication that could interact with psilocybin.I have high blood pressure or a fast heart rate.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Sham taVNS + Psilocybin + taVNS
- Group 2: Group 4: taVNS + Psilocybin + Sham taVNS
- Group 3: Group 2: Sham taVNS + Psilocybin + Sham taVNS
- Group 4: Group 3: Sham taVNS + Psilocybin + Treatment as Usual
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks are associated with the conjoined treatment of sham transcutaneous vagus nerve stimulation and psilocybin in Group 1?
"Group 1: Sham taVNS + Psilocybin + taVNS is deemed to have low safety due to the limited data available, which has resulted in a score of 1."
Answered by AI
Does this experiment encompass geriatric individuals?
"For this medical study, only persons aged 18 to 65 are eligible for participation. If someone is younger than that age range, there are 60 clinical trials available; whereas if someone is older than the specified age range, 380 different studies can be considered."
Answered by AI
Are there any remaining slots available for individuals to join this investigation?
"It appears, based on the clinicaltrials.gov listing, that this trial is not presently recruiting participants. Though initially posted to the website on September 1st 2023 and recently updated May 10th of the same year, no new patients are being sought at present. Nonetheless, 836 other medical studies have open recruitment periods currently underway."
Answered by AI
Am I eligible to join this research endeavor?
"The prospective enrollees should be in good health and within the ages of 18 to 65. This clinical trial is targeting 100 participants."
Answered by AI
Who else is applying?
What site did they apply to?
University of Wisconsin - Madison
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I’ve been wanting to try psychedelics to see if they might help my PTSD from childhood. And I’d like to do it in a clinical setting and not in a field at a music festival. :).
PatientReceived 2+ prior treatments
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