Clinical Trials Logo

Clinical Trial Summary

Tetrahydrocannabidiol (THC) is the psychoactive chemical in cannabis that makes people high. This study aims to dissect acute impairment of various forms of memory and learning by THC in cannabis compared to placebo. Impairment will be assessed via a short cognitive test battery and then subjects will complete four tasks in the fMRI scanner.


Clinical Trial Description

The protocol below is designed to begin dissecting acute impairment of various forms of memory and learning by THC in cannabis compared to placebo, in a 2-session per subject double-blind, random assignment, placebo-controlled counterbalanced design in young to middle-aged adults. The purpose of these experiments is to gather important pilot data to demonstrate proof of principle for a planned NIDA submission of a P50 center application that will examine cannabis's differential effects on the neural circuit underpinnings these various cognitive domains across the lifespan in much more detail. In other words, these pilot data will show NIDA that the investigators' methods and approaches work and are suitable for use in their proposed center grant application. Unlike in the planned P50, in these small-scale pilot studies the investigators are only concerned with comparing these disrupting effects using a single dose of THC versus placebo, without exploration of age, sleep, or sex-related differential effects or of different dose-related effects. Tasks tapping each of the major cognitive memory-related domains will be performed in the MRI scanner, to reveal the relevant underlying circuitry and its disruption by drug using functional MRI. Although each of the fMRI tasks is already implemented in the investigators' lab in other contexts, the investigators have never studied alteration of the fMRI tasks by THC. Neither have other investigators elsewhere used this approach. It is also important to point out that the dose of active THC to be administered is the same as that already used safely in the investigators' IRB-approved driving studies, one which subjects state subjectively (a blind to actual dose information) makes them feel moderately intoxicated, and similar to the amount that they would consume themselves recreationally. The study will consist of 3 days (screening visit and 2 dose days). In a randomized, counterbalanced, double-blind study, investigators will administer high THC marijuana or placebo marijuana using paced inhalation through a vaporizer. Following administration, subjects will provide subjectively-rated CNB intoxication using a verbal analog scale, a short cognitive test battery, then complete 4 fMRI paradigms within ~1.5 hours: a) MSDM task, b) MID task, c) RISE task, and d) Treadway Effort/Reward task. These tests will be counterbalanced across subjects and sessions to minimize order and fatigue effects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05116527
Study type Interventional
Source Hartford Hospital
Contact Cole Arnold, B.A
Phone 860-545-6794
Email Cole.Arnold@hhchealth.org
Status Recruiting
Phase Phase 1/Phase 2
Start date July 7, 2022
Completion date December 2025

See also
  Status Clinical Trial Phase
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT04199468 - THC and Ketamine Effects in Humans: Relation to Neural Oscillations and Psychosis Phase 1
Completed NCT04587700 - Analgesic Consumption in Chronic Marijuana Users Following Orthopedic Trauma Surgery
Not yet recruiting NCT05899946 - An Integrated Program to Promote Anti-cannabis Messages N/A
Active, not recruiting NCT02735954 - Colorado Marijuana Users Health Cohort
Completed NCT00842985 - Dronabinol Interactions in Humans N/A
Completed NCT04124432 - Behavioral Pharmacology of Cannabis and Nicotine Phase 1
Active, not recruiting NCT04693884 - Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise Early Phase 1
Recruiting NCT03078309 - The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients Early Phase 1
Active, not recruiting NCT03560934 - Tetrahydrocannabinol (THC) and Sleep Early Phase 1
Recruiting NCT04704271 - Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II Phase 1
Withdrawn NCT03245658 - The Effect of Cannabis in Pancreatic Cancer Phase 2
Completed NCT04911127 - Therapeutic Response of Cannabidiol in Rheumatoid Arthritis Phase 1
Not yet recruiting NCT05999383 - Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration Phase 2
Recruiting NCT04429568 - THC Crossover Study N/A
Completed NCT05554146 - Pain Inflammation and Cannabis in HIV N/A
Not yet recruiting NCT05320367 - A Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users Phase 1/Phase 2
Terminated NCT03251326 - Nabilone in Cannabis Users With PTSD Phase 1/Phase 2
Completed NCT02567344 - Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving N/A
Completed NCT00176085 - Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH Phase 1