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Clinical Trials/NCT05641766
NCT05641766
Not Yet Recruiting
Phase 2

Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks

Yale University1 site in 1 country50 target enrollmentAugust 31, 2025
ConditionsTHC
InterventionsTHCPlacebo
DrugsTHC

Overview

Phase
Phase 2
Intervention
THC
Conditions
THC
Sponsor
Yale University
Enrollment
50
Locations
1
Primary Endpoint
Changes in brain dynamics during the Sternberg Working Memory Task
Status
Not Yet Recruiting
Last Updated
10 months ago

Overview

Brief Summary

The purpose of this study is to use non-invasive brain imaging methods (MEG and EEG) to characterize the effects of THC on brain activity during learning.

Detailed Description

The goal of this study is to use multimodal MEG/EEG to gain novel insight into the acute effects of THC on neural noise and its interaction with the fast information processing dynamics of the brain's cognition-related functional neural networks.

Registry
clinicaltrials.gov
Start Date
August 31, 2025
End Date
December 1, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jose Cortes

Assistant Professor of Psychiatry

Yale University

Eligibility Criteria

Inclusion Criteria

  • Cannabis use at least once in the past 12 months
  • No cannabis use during the course of the study confirmed with negative urine toxicology at screening and on each test day
  • Good physical and mental health

Exclusion Criteria

  • Cannabis naïve individuals
  • Lifetime or current medical, psychiatric or psychosocial disorders or history that is deemed unsuitable for participation in the study per PI discretion.
  • Positive pregnancy test, lactation, or refusal to practice birth control for the duration of the study and for two weeks following completion
  • Major current or recent stressors
  • Positive urine drug test
  • Contraindication for Magnetic Resonance Imaging
  • Treatment with psychotropic medication as per discretion of the PI
  • IQ less than 80
  • Weight exceeding 166kg
  • Diagnosis of major psychotic or manic disorder in first-degree relatives.

Arms & Interventions

THC

Participants will receive THC into a rapidly flowing IV infusion.

Intervention: THC

Placebo

Participants will receive an equivalent amount (about 1-2 ml) of placebo (sterile 190 proof USP ethanol). The placebo does not produce any measurable blood alcohol levels or subjective/behavioral effects.

Intervention: Placebo

Outcomes

Primary Outcomes

Changes in brain dynamics during the Sternberg Working Memory Task

Time Frame: Baseline and starting at +15 minutes after start of IV THC or placebo administration

Changes in brain dynamics will be characterized during the Sternberg Working Memory Task where participants are presented with a list of items to memorize, followed by a memory maintenance period during which the subject must maintain the list of items in memory.

Secondary Outcomes

  • Visual Analog Scale (VAS)(Baseline and starting at +15 minutes after start of IV THC or placebo administration)
  • Clinician Administered Dissociative Symptoms Scale (CADSS)(Baseline and starting at +15 minutes after start of IV THC or placebo administration)

Study Sites (1)

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