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

Part of paid clinical trials in Hamden, Connecticut.

Sponsor
Yale University
Study ID
NCT06624137
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 12, 2024
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Serotonergic Psychedelic Arm
    Group (healthy or with psychological or neurological disorder) administered serotonergic psychedelic (psilocybin, DMT, LSD, 5-MeO-DMT, Ayahuasca, etc.) regardless of administration route.
  • Arm: Placebo Arm
    Group (healthy or with psychological or neurological disorder) administered placebo (diphenydramine, saline, niacin, etc.) regardless of administration route.

Primary Outcome Measure

Hierarchial Gaussian Filter (HGF)-estimated average precision-weighted prediction error change in the conditioned hallucinations and probabilistic reversal learning tasks [ Time Frame: 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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Connecticut Mental Health CenterHamdenConnecticut06517
Maximillian S Greenwald, BA
[email protected]
203-441-7213‬
West Haven VA Medical CenterWest HavenConnecticut06516
Maximillian S Greenwald, BA
[email protected]
4254959793

Find similar trials in Hamden, CT

By condition
Substance use disorderMigrainePTSD (post-traumatic stress disorder)
By specialty
Behavioral healthAddiction medicineNeurologyPsychiatryMental health
By research site
Connecticut Mental Health Center· Hamden, CTWest Haven VA Medical Center· West Haven, CT

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