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

ConditionTHC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorYale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • THC

    Drug

    Participants will receive THC into a rapidly flowing IV infusion.

  • Placebo

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: THCExperimental treatment 1 intervention
Group B: PlaceboOther 1 intervention

Trial outcomes

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.

Time frame
Baseline and starting at +15 minutes after start of IV THC or placebo administration

Secondary outcomes

1

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.

Time frame
Baseline and starting at +15 minutes after start of IV THC or placebo administration
2

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.

Time frame
Baseline and starting at +15 minutes after start of IV THC or placebo administration

Other outcomes

Sponsors and contacts

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Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: