Pilot fMRI Studies of Aging-Related Effects of THC
ConditionTHC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYale University
About this trial
The purpose of this study is to begin investigating acute impairment of various forms of memory and learning by Tetrahydrocannabinol (THC) in cannabis (CNB) compared to placebo, in a 2-session per subject double-blind, random assignment, placebo-controlled counterbalanced design in young to middle-aged adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
CNB use within past 2 years and felt "high" when used.
Able to read, speak, and understand English.
Able and willing to provide written informed consent, and willing to commit to the study protocol.
Disqualifiers
Current marijuana tolerance, desire to cut down, or cravings to use during periods of abstinence.
Positive screen for drug or alcohol (except CNB) on test day will result in rescheduling the appointment
History of adverse effects with CNB
CNB users who are abstaining
Trial design
Design model
Crossover
Treatments tested in this trial
THC
DrugParticipants will be administered 0.5g of vaporized THC cannabis (12% THC cannabis)
Placebo
DrugParticipants will be administered identical plant material from which all THC has been removed by solvent extraction.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: THC then PlaceboExperimental treatment 2 interventions
Group B: Placebo then THCPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
The Complex Working Memory Span (CWMS) Task- Items Recalled
CWMS Task assesses immediate plus delayed recall and working memory by assessing working memory capacity by presenting a list of stimuli to be recalled while simultaneously performing a secondary task. This task uses a fully crossed design which includes both same-domain CWMS conditions (e.g. verbal storage combined with verbal processing) as well as cross-domain CWMS conditions (e.g., verbal storage combined with spatial processing). Mean number of total items recalled.
Time frame
At sessions 1 and 2 while under fMRI, immediately post drug administration2
The Complex Working Memory Span (CWMS) Task- fMRI measure
CWMS Task assesses immediate plus delayed recall and working memory by assessing working memory capacity by presenting a list of stimuli to be recalled while simultaneously performing a secondary task. This task uses a fully crossed design which includes both same-domain CWMS conditions (e.g. verbal storage combined with verbal processing) as well as cross-domain CWMS conditions (e.g., verbal storage combined with spatial processing). BOLD signal Infrontal lobe.
Time frame
At sessions 1 and 2 while under fMRI, immediately post drug administration3
The Effort Expenditure for Reward Task (EEfRT)
(EEfRT) is an out-of-scanner measure of effort-based decision-making that utilizes a choice model ("easy-task" or "hard-task") in response to varying monetary rewards. This task assesses motivation in relation to reward magnitude, implicating the activation or suppression of dopaminergic pathways in the nucleus accumbens (NAcc). Percentage of hard-task choices across all levels of probability is calculated from all hard choices. Lower percentages of hard task choices indicate decreased motivation.
Time frame
At sessions 1 and 2 immediately post drug administration4
The Card-Guessing fMRI task
The Card-Guessing fMRI task (28) will be used to investigate the effects of acute THC intoxication on decision-making, risk-taking, and reward processing. This task involves various trial types including win, loss, disappointment, and relief, to assess how THC affects reward expectancy and prediction error processing during decision-making presented as the fMRI blood-oxygen-level-dependent (BOLD) signal in response to card-guessing task.
Time frame
At sessions 1 and 2 while under fMRI, immediately post drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Biopharmaceutical Research Company
Collaborator
Bloom Labs Cannabis Solutions
Collaborator
Source ClinicalTrials.gov