Clinical trial NCT05641766: Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks
Official title: Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: THC
Keywords: MEG
EEG
THC
Placebo
Working Memory
Neural Noise
Cognitive Process
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This proof-of-concept study will use a double-blind, randomized, cross-over (within-subject), placebo-controlled, counterbalanced study design in which participants will receive 0 (placebo) or 0.03 mg/kg intravenous THC over 20 minutes while undergoing simultaneous MEG/EEG data collection.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes in brain dynamics during the Sternberg Working Memory Task
timeFrame: Baseline and starting at +15 minutes after start of IV THC or placebo administration
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Baseline and starting at +15 minutes after start of IV THC or placebo administration
measure: Clinician Administered Dissociative Symptoms Scale (CADSS)
timeFrame: Baseline and starting at +15 minutes after start of IV THC or placebo administration
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System, Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Jose Cortes-Briones, PhD
role: PRINCIPAL_INVESTIGATOR
References: