Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: THC, Placebo.
- Who it may be relevant to
- Registry conditions: THC. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Changes in brain dynamics during the Sternberg Working Memory Task [Time frame: Baseline and starting at +15 minutes after start of IV THC or placebo administration]
Secondary outcome measures (2)
- Visual Analog Scale (VAS) [Time frame: Baseline and starting at +15 minutes after start of IV THC or placebo administration]
- Clinician Administered Dissociative Symptoms Scale (CADSS) [Time frame: Baseline and starting at +15 minutes after start of IV THC or placebo administration]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- VA Connecticut Healthcare System, Yale School of Medicine — West Haven
Identifiers
NCT: NCT05641766 · 2000033383 · 1R03DA054453-01A1