Pilot fMRI Studies of Aging-Related Effects of THC

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Olin Neuropsychiatric Research Center at Hartford Healthcare — Hartford

Идентификаторы

NCT: NCT06647524 · 2000032428 · HHC-2024-0186

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗