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

NCT ID: NCT05641766

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2025-12-01

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.

Conditions

THC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

THC

Participants will receive THC into a rapidly flowing IV infusion.

Group Type: EXPERIMENTAL

THC

Intervention Type: DRUG

Participants will receive THC into a rapidly flowing IV infusion.

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.

Group Type: OTHER

Placebo

Intervention Type: 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.

Interventions

THC

Participants will receive THC into a rapidly flowing IV infusion.

Intervention Type: DRUG

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 Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Jose Cortes

Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose Cortes-Briones, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

VA Connecticut Healthcare System, Yale School of Medicine

West Haven, Connecticut, United States

Countries

United States

Central Contacts

Jose Cortes-Briones, PhD

Role: CONTACT

jose.briones@yale.edu

203-903-5711 ext. 5539

Other Identifiers

1R03DA054453-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000033383

Identifier Type: -

Identifier Source: org_study_id