THC for Cognitive Function (THC-MEG Trial)

Phase 2

Waitlist Available

Led By Jose Cortes-Briones, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and starting at +15 minutes after start of iv thc or placebo administration

Summary

This trial uses brain scans to measure the effects of THC on brain activity while learning.

Who is the study for?

This trial is for individuals in good physical and mental health who have used cannabis at least once in the past year. They must not use cannabis during the study, confirmed by negative urine tests. People can't join if they've never used cannabis, are pregnant or breastfeeding without birth control, have certain medical or psychiatric conditions, take psychotropic drugs, have a low IQ (<80), weigh over 166kg, or have relatives with major psychotic disorders.

What is being tested?

The study investigates how THC affects brain activity related to learning using MEG and EEG imaging techniques. Participants will be given either THC or a placebo to compare their brain's response during tasks that involve working memory.

What are the potential side effects?

While the side effects of THC can vary widely among individuals, common ones include altered senses and sense of time, mood changes, impaired body movement coordination, difficulty with thinking and problem-solving as well as potential long-term cognitive effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and starting at +15 minutes after start of iv thc or placebo administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and starting at +15 minutes after start of iv thc or placebo administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and starting at +15 minutes after start of iv thc or placebo administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in brain dynamics during the Sternberg Working Memory Task

Secondary study objectives

Clinician Administered Dissociative Symptoms Scale (CADSS)

Visual Analog Scale (VAS)

Trial Design

2Treatment groups

Experimental Treatment

Group I: THCExperimental Treatment1 Intervention

Participants will receive THC into a rapidly flowing IV infusion.

Group II: PlaceboExperimental Treatment1 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

First Studied

Drug Approval Stage

How many patients have taken this drug

THC

2017

Completed Phase 1

~440

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