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TerminatedN/A

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

NCT06624137 · Yale University

Closed to entry
Status
Not accepting participants
Not applicable
Phase
5
Target enrolment
2
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Hierarchial Gaussian Filter (HGF)-estimated average precision-weighted prediction error change in the conditioned hallucinations and probabilistic reversal learning tasks

    Measured over Immediately post drug administration (when psychologically acceptable), 1 day post drug administration, 5-14 days post drug administration, and 4-6 weeks post drug administration

  • Auditory and visual conditioned hallucination rate change

    Measured over Immediately post drug administration (when psychologically acceptable), 1 day post drug administration, 5-14 days post drug administration, and 4-6 weeks post drug administration

  • Perseverative and jumping-to-conclusion error total change in probabilistic reversal learning task

    Measured over Immediately post drug administration (when psychologically acceptable), 1 day post drug administration, 5-14 days post drug administration, and 4-6 weeks post drug administration

  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) score change

    Measured over 1 day post drug administration, 5-14 days post drug administration, and 4-6 weeks post drug administration

  • Southampton Mindfulness Questionnaire (SMQ) score change

    Measured over 1 day post drug administration, 5-14 days post drug administration, and 4-6 weeks post drug administration

  • HGF-estimated ratio of perceptual belief-to-sensory evidence weighting change

    Measured over Immediately post drug administration (when psychologically acceptable), 1 day post drug administration, 5-14 days post drug administration, and 4-6 weeks post drug administration

  • Aberrant Salience Inventory (ASI) score change

    Measured over 1 day post drug administration, 5-14 days post drug administration, and 4-6 weeks post drug administration

  • Change in the exponent of the 1/f power spectrum law from resting state EEG

    Measured over Period of peak drug effect and 1 day after drug administration

  • Change in resting state delta, alpha, theta, low gamma, medium gamma, and high gamma bands

    Measured over Period of peak drug effect and 1 day after drug administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Participation in approved clinical protocol at Yale University involving potential administration of serotonergic psychedelics * Absence of pre-existing psychotic symptoms Exclusion Criteria: * Current intoxication based on self-report * Any neurological, medical or developmental problem that is known to impair cognition significantly based on self-report * History of seizures based on self-report * Contraindications for MR scanning including metallic implants of any kind, pacemakers and history of accidents with metal, claustrophobia (specific to those who will participate in MRI)

Where

2 study sites

FacilityCityRegionCountry
Connecticut Mental Health CenterHamdenConnecticutUnited States
West Haven VA Medical CenterWest HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06624137 on ClinicalTrials.gov →

Last updated in the registry 2026-07-09. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits