Cannabinoids, Learning, and Memory

Phase 1

Active, not recruiting

• Conditions: Cannabis; Psychotic Disorders
• Interventions: Drug: THC; Drug: Placebo

• Registration Number: NCT02407808
• Lead Sponsor: Yale University

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-03-31
• Study First Posted: 2015-04-03
• Primary Completion: 2018-08-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
THC	Placebo	Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes.
Placebo	THC	Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.
Placebo	Placebo	Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.
THC	THC	Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes.

Primary Outcome Measures

Name	Time	Method
Rey Auditory Verbal Learning Test (RAVLT)	+35 minutes after infusion	a measure of verbal episodic memory
N-Back Task	+65 minutes after infusion	a measure of working memory

Secondary Outcome Measures

Name	Time	Method
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	a measure of THC intoxication

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States