RecruitingNCT06624137

Computer Game, Qualitative, and MEG/EEG Assessment of Serotonergic Psychedelics

Computationally, Electrophysiologically, and Qualitatively Characterizing Serotonergic Psychedelics; Transdiagnostic Therapeutic and Pro-Psychotic Effects


Sponsor

Yale University

Enrollment

200 participants

Start Date

Dec 12, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This is an observational study which does NOT directly administer a psychedelic substance but rather recruits participants who are already participating in another clinical trial in which they may receive a serotonergic psychedelic. The goal of this observational study is to learn how the brain's information processing changes during and following administration of serotonergic psychedelics (psilocybin, N,N-Dimethyltryptamine/DMT, Lystergic Acid Diethylamide/LSD, etc.) for people with and without mental illness receiving serotonergic psychedelics through any clinical trial at Yale University. The main questions it aims to answer are: 1. Do serotonergic psychedelics cause the brain to rely on new information more than previously learned information while under the influence? What about 1 day, 5-14 days, and 4-6 weeks after use? 2. Do serotonergic psychedelics cause long-lasting side-effects in how people perceive (see, hear, feel, etc.) the world and how easily people change their beliefs? 3. How does the brain's electrical activity change after using serotonergic psychedelics? How does the balance between excitation and inhibition change while under their effect? 4. Can changes in how the brain uses information predict who will benefit from a psychedelic and who will have side effects from psychedelics? Researchers will compare with people given placebos to see what changes in brain processing are unique to serotonergic psychedelics. Participants will have the opportunity to do some combination of the following: 1. Online computer assessments consisting of games and questionnaires that probe how participants think. 2. Magnetoencephalography (MEG) or electroencephalography (EEG) with eyes closed and with repeated clicks, images, or sensations delivered. 3. A magnetic resonance imaging (MRI) scan. 4. Semi-structured qualitative interviews about their experience after taking a serotonergic psychedelic recorded via Zoom.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study uses computer tasks, brain imaging (MEG/EEG), and interviews to better understand how serotonergic psychedelics (drugs that act on serotonin receptors in the brain, such as psilocybin or ketamine) affect thinking, perception, and brain activity. It is an add-on study for participants already enrolled in other approved research involving these substances. **You may be eligible if...** - You are already participating in an approved Yale University clinical study that may involve psychedelic drug administration - You do not have any pre-existing symptoms of psychosis **You may NOT be eligible if...** - You are currently intoxicated - You have a medical, neurological, or developmental condition known to impair thinking - You have a history of seizures - You have metal implants, a pacemaker, or severe claustrophobia (for those participating in MRI scans) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSerotonergic Psychedelic

Any serotonergic or "classic" psychedelic that exhibits mainly Serotonin 2A receptor (5-HT2AR) agonism and is judged to produce subjectively similar effects.

DRUGPlacebo

Matched Placebo


Locations(2)

Connecticut Mental Health Center

Hamden, Connecticut, United States

West Haven VA Medical Center

West Haven, Connecticut, United States

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NCT06624137


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