Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT04855526 |
Other study ID # |
R-HHC-2019-0137 |
Secondary ID |
126663 |
Status |
Not yet recruiting |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
April 1, 2022 |
Est. completion date |
June 30, 2022 |
Study information
Verified date |
January 2022 |
Source |
Hartford Hospital |
Contact |
Chelsea N Meagher, BA |
Phone |
860-545-7106 |
Email |
chelsea.meagher[@]hhchealth.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Memory deficits are one of the most consistently observed cognitive effects of marijuana use.
There is evidence that some decrements attributable to the primary psychoactive ingredient,
delta-9-tetrahydrocannabinol (THC), may be attenuated by cannabidiol (CBD). This study will
help us learn more about the relationship between THC and CBD consumption with memory
processes. A combination of MRI and neuropsychological tests (which are computer and
paper/pencil tasks) will be used to measure the neurocognitive and behavioral impacts of THC
and CBD use.
Description:
With increased legalization and medicalization of marijuana (MJ), there is an urgent need to
understand the acute effects of use. One of the most consistently observed cognitive outcomes
associated with MJ use is memory dysfunction, which may have a substantial impact on daily
life in individuals using MJ for recreational or medicinal purposes. Notably, there are
numerous preparations of MJ with varying proportions of cannabinoids, which may differ in
behavioral and cognitive effects. For instance, there is emerging evidence that acute
administration of delta-9-tetrahydrocannabinol (THC), the main psychoactive constituent of
MJ, hinders memory and reduces prefrontal and hippocampal functional magnetic resonance
imaging (fMRI) activation, but cannabidiol (CBD) may mitigate some of these impairments.
Given the role of glutamate in learning and memory, the investigators suggest that these
effects may be subserved, in part, by glutamatergic mechanisms. The investigators will use
magnetic resonance spectroscopy (MRS) to non-invasively measure glutamate in order to explore
the neurochemical underpinnings of memory-related fMRI response changes following acute
administration of THC and CBD in a randomized, double-blind, placebo-controlled, cross-over
design. A total of 9 healthy participants ages 18-40 will be enrolled. Participants will
first undergo one screening visit (~4 hours), comprising informed consent, assessment of
health history, psychiatric diagnoses, cognitive function, and substance use history, and a
structural MRI session. This will be followed by 3 separate MJ dose visits (~4 hours each),
at which participants will complete neuroimaging after administration of one of 3
preparations of vaporized MJ in a randomized, counterbalanced, double-blinded fashion: 1)
high THC and no CBD (THC), 2) high THC and high CBD (THC+CBD), and 3) no THC and no CBD
(placebo MJ). As in the investigator's ongoing studies, bulk MJ plant material will be
provided by the National Institute on Drug Abuse. MJ dose visits will comprise MJ
administration, blood collection, MRS/fMRI scan, subjective reports, and a brief cognitive
assessment.