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

Sponsor

Yale University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05641766

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
THC	Drug: THC Other: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Changes in brain dynamics during the Sternberg Working Memory Task [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
Diagnosis of major psychotic or manic disorder in first-degree relatives.