Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647524
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Pilot FMRI Studies of Aging-Related Effects of THC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot FMRI Studies of Aging-Related Effects of THC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inclusionexclusion criteria cognitivepersonality 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 15 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 snacksmeals 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
On an initial Screening Visit regular or novice cannabis CNB users will undergo informed consent clinical assessment to fully evaluate inclusionexclusion criteria cognitivepersonality 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 15 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 snacksmeals 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None