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NCT02407808 Clinical Trial

Cannabinoids, Learning, and Memory

Psychotic Disorders Clinical Trial

— THC-Memory  

Official title:
Cannabinoids, Learning, and Memory

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02407808
Other study ID # 1501015211
Secondary ID No NIH funding
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date February 2015
Est. completion date August 2024

Study information
Verified date October 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overarching goal of this study is to characterize the effects of cannabinoids on working and episodic memory.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 80
Est. completion date August 2024
Est. primary completion date August 10, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States VA Connecticut Healthcare System West Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rey Auditory Verbal Learning Test (RAVLT) a measure of verbal episodic memory +35 minutes after infusion
Primary N-Back Task a measure of working memory +65 minutes after infusion
Secondary Clinician Administered Dissociative Symptoms Scale (Total Score) Baseline, +10, +85, and +240 minutes after the first infusion
Secondary Visual Analog Scale (Total Score) a measure of THC intoxication Baseline, +10, +85, +240 minutes after the first infusion
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