Cannabinoids, Learning, and Memory
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Yale University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Rey Auditory Verbal Learning Test (RAVLT)
Study Overview
Brief Summary
The overarching goal of this study is to characterize the effects of cannabinoids on working and episodic memory.
Detailed Description
This study will be achieved by studying the acute effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive component of cannabis and a cannabinoid-1 receptor (CB1R) agonist, on a wide range of memory tasks in healthy human subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women aged 18 and 55 years (extremes included) on day of first dosing
- •Exposed to cannabis at least once in their lifetime
Exclusion Criteria
- •Cannabis naive
- •Positive pregnancy screen during screening
- •Hearing deficits
Arms & Interventions
Placebo
Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.
Intervention: Placebo (Drug)
THC
Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes.
Intervention: THC (Drug)
THC
Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes.
Intervention: Placebo (Drug)
Placebo
Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.
Intervention: THC (Drug)
Outcomes
Primary Outcomes
Rey Auditory Verbal Learning Test (RAVLT)
Time Frame: +35 minutes after infusion
a measure of verbal episodic memory
N-Back Task
Time Frame: +65 minutes after infusion
a measure of working memory
Secondary Outcomes
- Clinician Administered Dissociative Symptoms Scale (Total Score)(Baseline, +10, +85, and +240 minutes after the first infusion)
- Visual Analog Scale (Total Score)(Baseline, +10, +85, +240 minutes after the first infusion)
Investigators
Mohini Ranganathan
Associate Professor
Yale University