Psilocybin for Perception Disturbance

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Perception Disturbance+3 More
Psilocybin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effects of the drug psilocybin on visual perception, compared to an active placebo control.

Eligible Conditions
  • Perception Disturbance
  • Psychedelic Experiences
  • Visual Suppression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 21 Secondary · Reporting Duration: 3-5 hours

3-5 hours
Difference in Event Related Potential Amplitude
Psychophysical Discrimination Threshold
Approximately 4 weeks
Change in resting state brain activity
Change of white matter structural connectivity
approximately 4 weeks
5 Dimensions of Altered States of Consciousness (5D-ASC)
Change in Serum Brain-Derived Neurotrophic Factor (BDNF)
Change in Serum C-Reactive Protein (CRP)
Change in Serum Glial Fibrillary Acidic Protein (GFAP)
Change in Serum Interferon Gamma (IFNy)
Change in Serum Interleukin-10 (IL-10)
Change in Serum Interleukin-1beta (IL-1b)
Change in Serum Interleukin-6 (IL-6)
Change in Serum S100 Calcium-Binding Protein B (S100B)
Change in Serum Transforming Growth Factor Beta-1 (TGFb-1)
Change in Serum Tumor Necrosis Factor Alpha (TNFa)
Change in Serum Tumor Necrosis Factor Receptor 1 (TNF-R1)
Change in Serum Tumor Necrosis Factor Receptor 2 (TNF-R2)
Change in Serum Ubiquitin C-Terminal Hydrolase L1 (UCHL-1)
Ego-Dissolution Inventory (EDI)
Positive and Negative Affect Schedule (PANAS) Negative Scale
Positive and Negative Affect Schedule (PANAS) Positive Scale
Revised Mystical Experience Questionnaire (RMEQ-30)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Psilocybin
44%Headache
21%Nausea
15%Anxiety
8%Suicidal Ideation
6%Insomnia
6%Depressed mood
4%Alcohol poisoning
4%Pneumonia
4%Viral upper resp. tract infection
4%Depression
4%Corona virus infection
4%Vomiting
4%Upper respiratory tract infection
4%Abdominal pain upper
2%Musculoskeletal pain
2%Dizziness
2%Pain
2%Limb injury
2%Abdominal pain
2%Blood pressure increased
2%Urinary incontinence
2%Cataract
2%Testicular pain
2%Toothache
2%Illusion
2%Fatigue
2%Psychomotor hyperactivity
2%Skin cosmetic procedure
2%Food allergy
2%Muscle strain
2%Back pain
2%Food poisoning
2%Alcohol withdrawal syndrome
2%Dysphoria
2%Nasal congestion
2%Photopsia
2%Myalgia
2%Palpitations
2%Dyspepsia
2%Biopsy cervix
2%Gingivitis
2%Diverticulitis
2%Asthenia
2%Influenza
2%Oropharyngeal pain
2%Hyperventilation
2%Blood pressure diastolic increased
2%Dyspnea
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02061293) in the Psilocybin ARM group. Side effects include: Headache with 44%, Nausea with 21%, Anxiety with 15%, Suicidal Ideation with 8%, Insomnia with 6%.

Trial Design

2 Treatment Groups

Niacin First
1 of 2
Psilocybin First
1 of 2
Experimental Treatment

75 Total Participants · 2 Treatment Groups

Primary Treatment: Psilocybin · No Placebo Group · Phase 1

Niacin FirstExperimental Group · 2 Interventions: Psilocybin, Niacin · Intervention Types: Drug, Drug
Psilocybin FirstExperimental Group · 2 Interventions: Psilocybin, Niacin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved
Niacin
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3-5 hours

Who is running the clinical trial?

Heffter Research InstituteOTHER
13 Previous Clinical Trials
435 Total Patients Enrolled
University of MinnesotaLead Sponsor
1,239 Previous Clinical Trials
1,460,603 Total Patients Enrolled
Sophie Jungers, BSStudy DirectorUniversity of Minnesota
Link Swanson, PhD(c)Study DirectorUniversity of Minnesota
Jessica Nielson, PhDPrincipal InvestigatorUniversity of Minnesota

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You agree to refrain from using recreational drugs while enrolled in the study.
You have given informed consent.
You have at least a high-school level of education or equivalent (e.g.
You are in good physical and mental health.
You have taken psilocybin at least once.
You must have a person that can reliably transport you to and from the CRU for dosing sessions.
You are located in Minnesota counties that are approximately within 1 hour driving distance to Twin Cities, including not limited to Hennepin, Ramsey, Washington, Anoka, Wright, Carver, Scott, Dakota, Sherburn.
Participants must be up-to-date on COVID-19 vaccines, per CDC guidelines, and share a copy of their proof of vaccination status with the study team prior to the consenting visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: October 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Minnesota30.0%
Wisconsin20.0%
Nebraska10.0%
Other40.0%
How old are they?
18 - 6577.8%
65+22.2%
What site did they apply to?
University of Minnesota100.0%
What portion of applicants met pre-screening criteria?
Met criteria78.9%
Did not meet criteria21.1%

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. University of Minnesota: < 24 hours
Typically responds via
Email100.0%