THCPhase 2THC-MEGNCT05641766
Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks
A Phase 2 study testing THC in people with THC, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- THC
- What is being tested?
- THC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2025to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, 06516
Jose Cortes-Briones, PhD
About this study
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.
Read the 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
- Being tested
- THC, Placebo
- Keywords
- MEG, EEG, THC, Placebo, Working Memory, Neural Noise, Cognitive Process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THCDrug
Participants will receive THC into a rapidly flowing IV infusion.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| THC | Experimental | Participants will receive THC into a rapidly flowing IV infusion. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and starting at +15 minutes after start of IV THC or placebo administration
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and starting at +15 minutes after start of IV THC or placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start31 Aug 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THCStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jose Cortes, Yale University
- Investigators
- Jose Cortes-Briones, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641766
- Sponsor's protocol ID
- 2000033383
- Other IDs
- 1R03DA054453-01A1
- Acronym
- THC-MEG
- Status last verified
- Jun 2025
- First submitted
- 29 Nov 2022
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks
- ClinicalTrials.gov ID
- NCT05641766
- Acronym / sponsor ID
- THC-MEG / 2000033383
- Conditions
- THC
- Keywords
- MEG, EEG, THC, Placebo, Working Memory, Neural Noise, Cognitive Process
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| THC | Experimental | Drug: THCParticipants will receive THC into a rapidly flowing IV infusion. |
| Placebo | Other | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THCParticipants will receive THC into a rapidly flowing IV infusion. | Drug | THC |
| PlaceboParticipants 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 |
Primary outcome
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
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose Cortes-Briones, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THC in people with THC, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Cortes-Briones, PhD (203-903-5711 ext. 5539, jose.briones@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.