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Recruiting NCT06647524

Pilot fMRI Studies of Aging-Related Effects of THC

Phase II Interventional THC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: THC, Placebo.
Who it may be relevant to
Registry conditions: THC. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug THC
    Participants will be administered 0.5g of vaporized THC cannabis (12% THC cannabis)
  • Drug Placebo
    Participants will be administered identical plant material from which all THC has been removed by solvent extraction.

Primary outcome measures

  • The Complex Working Memory Span (CWMS) Task- Items Recalled [Time frame: At sessions 1 and 2 while under fMRI, immediately post drug administration]
  • The Complex Working Memory Span (CWMS) Task- fMRI measure [Time frame: At sessions 1 and 2 while under fMRI, immediately post drug administration]
  • The Effort Expenditure for Reward Task (EEfRT) [Time frame: At sessions 1 and 2 immediately post drug administration]
  • The Card-Guessing fMRI task [Time frame: At sessions 1 and 2 while under fMRI, immediately post drug administration]
  • The Zibrio SmartScale [Time frame: At sessions 1 and 2 while under fMRI, immediately post drug administration]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Olin Neuropsychiatric Research Center at Hartford Healthcare — Hartford

Identifiers

NCT: NCT06647524 · 2000032428 · HHC-2024-0186

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗