Clinical trial NCT06647524: Pilot fMRI Studies of Aging-Related Effects of THC
Official title: Pilot fMRI Studies of Aging-Related Effects of THC
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: THC
Keywords: Memory Impairment
Learning Impairment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Biopharmaceutical Research Company
name: Bloom Labs Cannabis Solutions
First posted: 2024-10-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

On an initial Screening Visit, regular or novice cannabis (CNB) users will undergo informed consent, clinical assessment (to fully evaluate inclusion/exclusion criteria), cognitive/personality assessment, and a structural MRI scan.

At each assessment, subjects will provide subjectively-rated CNB intoxication using a verbal analog scale, complete 2 fMRI paradigms within \~1.5 hours: a) Card Guessing task and b) Complex Working Memory Span, and complete the computer-based Effort Expenditure for Reward Task within \~2 hours. These tests will be counterbalanced across subjects and sessions to minimize order and fatigue effects. Breaks will be standardized in a private environment and snacks/meals provided. Bathroom visits given as needed. Subjects will be supervised at all times by study staff and vital signs monitored. On assessment days, participants will remain at the Olin NRC until they report no subjective intoxication, and are observed by study staff to be no longer objectively intoxicated, then use taxi or Uber transportation home.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* IQ \<80 on the Wechsler Abbreviated Scale of Intelligence
* Inability to comprehend written instructions using the WRAT 4 reading achievement test
* Pregnant, breastfeeding, and ineffective birth control methods
* Unable or unsafe to have an MRI
* Serious medical, neuro-ophthalmological, or neurological illness (e.g. cancer, seizure disorders, encephalopathy
* History of head trauma with loss of consciousness \> 30 minutes or concussion lasting 30 days
* Focal brain lesion seen on structural MRI
* Any medical/neurological condition that could compromise neurocognitive performance (e.g. epilepsy, multiple sclerosis, fetal alcohol syndrome)
* Anyone deemed unsafe to study personnel for any reason
* Hearing loss such that subject cannot hear sounds at the levels (dB) or pitches (Hz) to be used in the study
* Significant pain and/or reduced mobility in the arms

Primary outcomes:
measure: The Complex Working Memory Span (CWMS) Task- Items Recalled
timeFrame: At sessions 1 and 2 while under fMRI, immediately post drug administration
measure: The Complex Working Memory Span (CWMS) Task- fMRI measure
timeFrame: At sessions 1 and 2 while under fMRI, immediately post drug administration
measure: The Effort Expenditure for Reward Task (EEfRT)
timeFrame: At sessions 1 and 2 immediately post drug administration
measure: The Card-Guessing fMRI task
timeFrame: At sessions 1 and 2 while under fMRI, immediately post drug administration
measure: The Zibrio SmartScale
timeFrame: At sessions 1 and 2 while under fMRI, immediately post drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Olin Neuropsychiatric Research Center at Hartford Healthcare
state: Connecticut
Study officials:
affiliation: Founding Director, Olin Neuropsychiatry Center; Yale University
name: Godfrey Pearlson, M.D
role: PRINCIPAL_INVESTIGATOR
References: