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Psychedelic
Psilocybin for Psychedelic Experiences (i2 Trial)
Phase 1
Recruiting
Led By Robin Carhart-Harris, PhD
Research Sponsored by Robin Carhart-Harris, PhD, MA
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 baseline (visit 0) vs 4 weeks post visit 4
Awards & highlights
i2 Trial Summary
This trial will study the mental and physical reactions that arise during a psychedelic experience, using MRI scans and interviews with 12 healthy volunteers. Doses of psilocybin will be given with breaks to assess reactions during the experience.
Who is the study for?
This trial is for healthy adults aged 21-70 with prior psychedelic experience, but not more than 500 times. They must be able to swallow pills, use technology for data entry, and speak English fluently. Women of childbearing potential must agree to effective contraception; men also need to practice birth control and not donate sperm during the study.Check my eligibility
What is being tested?
The study tests how psilocybin affects mental states and physical reactions using MRI scans in participants who have used psychedelics before. It involves four doses of psilocybin over several weeks, with brain imaging sessions after each dose while answering questions about their experiences.See study design
What are the potential side effects?
While specific side effects are not listed, typical reactions to psilocybin can include changes in perception, mood swings, nausea, disorientation or confusion which usually resolve within hours after the drug wears off.
i2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (visit 0) vs 4 weeks post visit 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (visit 0) vs 4 weeks post visit 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The WHO - Five Well-Being Index (WHO-5)
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%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Hypoesthesia
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
i2 Trial Design
1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
Healthy volunteers will receive up to four doses of psilocybin separated from each other by at least one week. The first dosing session will involve 10 mg psilocybin, the remaining three dosing sessions will receive up to 25mg psilocybin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Robin Carhart-Harris, PhD, MALead Sponsor
Robin Carhart-Harris, PhDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had a severe bad reaction to a psychedelic.I do not have any serious health conditions that would make me unsuitable for the study.I can swallow pills or capsules.I have a psychiatric disorder that affects my daily life and study participation.A close family member has or had schizophrenia or a similar condition.I am not using any drugs or alcohol excessively, including cannabis.My heart's electrical activity is abnormal or I have heart damage.I am not pregnant, will use effective birth control, and won't donate sperm during the study.You have used psychedelic substances no more than 500 times in the past. It's better if you have some experience with psychedelics without any negative reactions, but too much experience might mean you have abused these substances.I am not pregnant, will use effective birth control, and am not breastfeeding if I can become pregnant.I am between 21 and 70 years old.You have used a psychedelic drug before.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin
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.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05698511 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals being included in the current recruitment for this research endeavor?
"This study requires that participants are aged 21 or above and no older than 70."
Answered by AI
Could you please explain any potential risks associated with Psilocybin consumption?
"Though there is evidence of Psilocybin's safety, its lack of efficacy data places it on a scale of 2."
Answered by AI
Is recruitment still open for this research endeavor?
"As per the information posted at clinicaltrials.gov, this investigation is no longer taking on participants - as evidenced by its initial posting date of February 1st 2023 and latest update on January 13th 2023. Nevertheless, there are still 822 other trials available for those seeking to enrol in a medical study."
Answered by AI
Might I be accepted as a participant in this investigation?
"This medical experiment requires 12 individuals between 21 and 70 years old possessing neuroimaging to have previously experienced a psychedelic substance no more than 500 times, not responding adversely in the past, fluent in English language, able to swallow pills/capsules, non-pregnant with an effective form of birth control or contraception agreed upon by participant (or male participants agreeing they will not donate sperm during study period), willing and capable of providing informed consent, competent at using computers/tablets/phones for data entry as well as alerting investigators within 48 hours if any new or changed conditions occur."
Answered by AI
Who else is applying?
What state do they live in?
New Mexico
California
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
University of California, San Francisco
Why did patients apply to this trial?
I nterested in improving daily mood. I am curious as to the lasting effects on the mind for well being.
PatientReceived 2+ prior treatments
I want to help! And I find this application of psychedelics fascinating!
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
When will I hear from you? I'm wondering about the listed side effects. Specifically, if any side effects are experienced, are they temporary, or long lasting?
PatientReceived 1 prior treatment
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