Clinical TrialNeuroimaging & Brain MeasuresPlaceboRecruiting

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

Observational prospective study (n=200) using computer tasks, MEG/EEG and MRI to assess how serotonergic psychedelics (psilocybin, DMT, LSD, etc.) alter brain information processing in people receiving these compounds through Yale clinical trials.

Target Enrollment
200 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

This prospective observational study will measure changes in how the brain represents and uses new versus previously learned information before, during, and after administration of serotonergic psychedelics given in parent clinical trials at Yale.

Assessments include 3–4 online computer games and questionnaires, MEG or EEG (eyes closed and evoked responses), and structural MRI at baseline, acute (day of), 1 day, 5–14 days, and 4–6 week follow-ups; semi-structured qualitative interviews may also be performed.

Participants may be in active or placebo arms of parent trials; analyses will compare psychedelic versus placebo conditions and explore whether neural processing changes predict therapeutic benefit or psychotic‑like side effects.

Study Arms & Interventions

Serotonergic psychedelic

experimental

Participants receiving a serotonergic psychedelic as part of a Yale clinical trial (various compounds and routes).

Interventions

  • Compound
    • varied

    Includes psilocybin, DMT, LSD, 5‑MeO‑DMT, ayahuasca etc.; dosing and route per parent trial; measures taken before, during, and after administration.

Placebo

inactive

Participants receiving placebo as part of a parent trial.

Interventions

  • Placebo
    • varied

    Matched placebo (eg. diphenhydramine, saline, niacin) per parent trial.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Participation in approved clinical protocol at Yale University involving potential administration of serotonergic psychedelics
  • Absence of pre-existing psychotic symptoms

Exclusion Criteria

  • 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)

Study Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment200 participants
  • Timeline
    Start: 2024-12-12
    End: 2028-05-01
  • Compound
    Placebo
  • Topic
    Neuroimaging & Brain Measures

Locations

Connecticut Mental Health Center — Hamden, Connecticut, United States
West Haven VA Medical Center — West Haven, Connecticut, United States

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