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Cannabinoids, Learning, and Memory (THC-Memory)

Primary Purpose

Cannabis, Psychotic Disorders

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
THC
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cannabis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

THC

Placebo

Arm Description

Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes.

Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.

Outcomes

Primary Outcome Measures

Rey Auditory Verbal Learning Test (RAVLT)
a measure of verbal episodic memory
N-Back Task
a measure of working memory

Secondary Outcome Measures

Clinician Administered Dissociative Symptoms Scale (Total Score)
Visual Analog Scale (Total Score)
a measure of THC intoxication

Full Information

First Posted
March 31, 2015
Last Updated
October 12, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02407808
Brief Title
Cannabinoids, Learning, and Memory
Acronym
THC-Memory
Official Title
Cannabinoids, Learning, and Memory
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 10, 2018 (Actual)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis, Psychotic Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
THC
Arm Type
Active Comparator
Arm Description
Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.
Intervention Type
Drug
Intervention Name(s)
THC
Intervention Description
Active THC (0.0015-0.03 mg/kg) administered over 20 minutes.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.
Primary Outcome Measure Information:
Title
Rey Auditory Verbal Learning Test (RAVLT)
Description
a measure of verbal episodic memory
Time Frame
+35 minutes after infusion
Title
N-Back Task
Description
a measure of working memory
Time Frame
+65 minutes after infusion
Secondary Outcome Measure Information:
Title
Clinician Administered Dissociative Symptoms Scale (Total Score)
Time Frame
Baseline, +10, +85, and +240 minutes after the first infusion
Title
Visual Analog Scale (Total Score)
Description
a measure of THC intoxication
Time Frame
Baseline, +10, +85, +240 minutes after the first infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohini Ranganathan, M.D.
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

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Cannabinoids, Learning, and Memory

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