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Psychedelic
Psilocybin for Perception Disorders
Phase 1
Recruiting
Research Sponsored by University of California, Berkeley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are able to swallow capsules.
Are ≥21 years of age at time of Informed Consent Form signing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up statistical tests will be performed after all data collection is complete.
Awards & highlights
Study Summary
This trial will test how psilocybin affects visual perception and the brain's representation of the visual environment. fMRI will be used to measure brain activity in different brain areas while subjects are performing a visual perceptual task.
Who is the study for?
This trial is for healthy adults over 21 who can swallow capsules and agree to birth control if applicable. They must attend all study visits, have a support person for post-dosing safety, and inform researchers of medical changes. Excluded are those with poor liver or kidney function, recent drug use including psychedelics, certain medication use, psychiatric disorders, MRI contraindications like metal implants or claustrophobia, uncontrolled hypertension or heart issues.Check my eligibility
What is being tested?
The trial studies how psilocybin affects visual perception by using fMRI scans while participants do visual tasks. It aims to identify brain areas involved in the altered perception caused by psilocybin in a diverse group of healthy subjects.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects from psilocybin may include nausea, headache, dizziness, altered sense of time and reality (hallucinations), mood swings (anxiety or euphoria), and increased blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
Select...
I am 21 years old or older.
Select...
I have someone to take me home safely after treatment.
Select...
I have someone to take me home safely after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ functional mri recordings will begin approximately 30 minutes after oral administration of experimental or comparator arm treatment and will continue for up to two hours.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~functional mri recordings will begin approximately 30 minutes after oral administration of experimental or comparator arm treatment and will continue for up to two hours.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amplitude and pattern of fMRI cortical responses
Secondary outcome measures
Participant-reported Subjective Effects
Perceptual measurements
Voxelwise modeling
Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Trial Design
2Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Psilocybin 0-14 mg, before fMRI measurement
Group II: ComparatorExperimental Treatment1 Intervention
Psilocybin 0-14 mg, before fMRI measurement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of California, BerkeleyLead Sponsor
181 Previous Clinical Trials
721,076 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use effective birth control during the study.I can swallow pills.I can commit to all study requirements, including visits and evaluations.I have someone to take me home safely after treatment.I haven't taken any vasoactive drugs like sildenafil or calcium channel blockers in the last 48 hours.I am 21 years old or older.I haven't taken any drugs linked to serotonin syndrome within 48 hours.My liver tests are within normal limits, except I have Gilbert syndrome.I have serious heart issues or abnormal heart rhythm measurements.You have recently thought about hurting yourself or have tried to hurt yourself, and the study doctor thinks you might still be at risk of doing so.I regularly take medication for mental health, like antidepressants or mood stabilizers.I am not taking medications like diclofenac or probenecid with psilocybin.I am not taking any medications that are not allowed in the study.I can avoid alcohol, certain medications, and drugs around my treatment times.My kidney function is poor, with eGFR or CrCl rates below 30 mL/min.I can swallow capsules.I agree to use effective birth control during the study.You are allergic to any of the ingredients in the experimental drug.I have someone to take me home safely after treatment.My blood pressure or heart rate is higher than normal.
Research Study Groups:
This trial has the following groups:- Group 1: Comparator
- Group 2: Experimental
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are participants being admitted to this experiment presently?
"According to clinicaltrials.gov, this medical trial is no longer accepting patients for enrollment. Initially posted on October 1st 2022 and last edited on July 26th of the same year, 13 other studies are currently open to potential participants."
Answered by AI
What potential risks are associated with utilizing psilocybin therapeutically?
"The limited data supporting psilocybin's safety and efficacy lead to our team at Power ranking it as a 1 on the scale of safety."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
Florida
Other
California
How old are they?
65+
18 - 65
What site did they apply to?
University of California, Berkeley
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I am excited about advancing research. I am curious about how psilocybin affect visual perception.
PatientReceived no prior treatments
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