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

NCT05641766 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: 20000333831R03DA054453-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

THC

Keywords

MEG; EEG; THC; Placebo; Working Memory; Neural Noise; Cognitive Process

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (2)

THC

EXPERIMENTAL

Participants will receive THC into a rapidly flowing IV infusion.

Drug: THC

Placebo

OTHER

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

Interventions

THC DRUG

Participants will receive THC into a rapidly flowing IV infusion.

THC

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

VA Connecticut Healthcare System, Yale School of Medicine

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Jose Cortes-Briones, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Cortes-Briones, PhD

CONTACT

203-903-5711; jose.briones@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: August 31, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)