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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: THC
• Intervention / Treatment: Drug: THC; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jose Cortes-Briones, PhD; Phone Number: 5539 203-903-5711; Email: jose.briones@yale.edu

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System, Yale School of Medicine
      • Principal Investigator: Jose Cortes-Briones, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THC; Participants will receive THC into a rapidly flowing IV infusion.	Drug: THC; Participants will receive THC into a rapidly flowing IV infusion.
Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in brain dynamics during the Sternberg Working Memory Task	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.	Baseline and starting at +15 minutes after start of IV THC or placebo administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	To confirm the acute effects of THC, feeling states associated with cannabis intoxication will be measured using a self-reported visual analogue scale of four feeling states ("high","anxious","calm and relaxed", and "tired") associated with cannabis effects. Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11mm line from 0=not at all to 100=extremely.	Baseline and starting at +15 minutes after start of IV THC or placebo administration
Clinician Administered Dissociative Symptoms Scale (CADSS)	To confirm the acute effects of cannabis, perceptual alterations will be measured using the CADSS. This is a scale consisting of 19 self-report items and 8 clinician-rated items scored 0=not at all to 4=extremely. The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.	Baseline and starting at +15 minutes after start of IV THC or placebo administration

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jose Cortes-Briones, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: EEG; MEG; THC; Placebo; Working Memory; Neural Noise; Cognitive Process
• Other Study ID Numbers: 2000033383; 1R03DA054453-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No