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

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.

Conditions

• Opioid Use Disorder
• OCD
• Major Depressive Disorder (MDD)
• Alcohol Use Disorder (AUD)
• Healthy Volunteer
• Migraine
• PTSD
• PTSD - Post Traumatic Stress Disorder
• Addiction
• Tobacco Use Disorder
• Obsessive Compulsive Disorder (OCD)

Interventions

DRUG

Serotonergic Psychedelic

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

DRUG

Placebo

Matched Placebo

Sponsors & Collaborators

• Burroughs Wellcome

  collaborator INDUSTRY

• National Institutes of Health (NIH)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Maximillian S Greenwald, BA · Yale University

• Albert R Powers, MD, PhD · Yale University

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-12

Primary Completion

2028-05-31

Completion

2028-05-31

Countries

• United States

Study Locations