THC-Memory: Cannabinoids, Learning, and Memory

• Sponsor: Yale University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02407808
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 101.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cannabis; Psychotic Disorders	Drug: THC; Drug: Placebo	Phase 1

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
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Cannabinoids, Learning, and Memory
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Aug 10, 2018
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Rey Auditory Verbal Learning Test (RAVLT) [+35 minutes after infusion]

   a measure of verbal episodic memory

2. N-Back Task [+65 minutes after infusion]

   a measure of working memory

Secondary Outcome Measures

1. Clinician Administered Dissociative Symptoms Scale (Total Score) [Baseline, +10, +85, and +240 minutes after the first infusion]

2. Visual Analog Scale (Total Score) [Baseline, +10, +85, +240 minutes after the first infusion]

   a measure of THC intoxication

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System	West Haven	Connecticut	United States	06516

Sponsors and Collaborators

• Yale University

Investigators

• Principal Investigator: Mohini Ranganathan, M.D., Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohini Ranganathan, Associate Professor, Yale University
• ClinicalTrials.gov Identifier: NCT02407808
• Other Study ID Numbers: 1501015211
• First Posted: Apr 3, 2015
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Additional relevant MeSH terms: Mental Disorders; Psychotic Disorders

Study Results

No Results Posted as of Aug 1, 2022