Yale University School of Medicine
New Haven, Connecticut, 06511, United States
Location status: Recruiting
NCT Number: NCT05472818
The main purpose of this study is to determine whether hippocampal synaptic vesicle density estimated by hippocampal [11C]APP-311/[11C]UCB-J binding in individuals diagnosed with cannabis use disorder (CUDs) improves with at least 4 weeks of confirmed abstinence from cannabis, in comparison to healthy controls (HCs). Furthermore, any change in synaptic vesicle density will be placed in functional context by measuring verbal memory, which is sensitive to hippocampal function, before and after at least 4 weeks of confirmed abstinence. Finally, the relationship between hippocampal [11C]UCB-J binding in CUDs with measures of cannabis exposure (e.g., age of initiation, cumulative lifetime dose) will be explored.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Early Phase 1
New Haven, Connecticut, 06511, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
CUD Participants Inclusion Criteria:
CUD Participants Exclusion Criteria:
Healthy Controls Inclusion Criteria:
Healthy Controls Exclusion Criteria:
For each [11C]APP311 (UCB-J) PET scan, up to 20 mCi of [11C]APP311 (UCB-J) will be administered by infusion pump. All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart. Approximately 8 CUD participants will be asked to return for a third [11C]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan.
Time frame: All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart.
Hippocampal SV2A synaptic density will be measured using [11C]APP311 (UCB-J).
Time frame: The Auditory Verbal Learning Task (AVLT) will be administered before and after the 4 week abstinence period.
To determine the relationship between hippocampal [11C]APP311 (UCB-J) binding and performance on the hippocampal verbal memory task (Auditory Verbal Learning Task [AVLT]), a cognitive task that measures total immediate recall, before and after 4 weeks of confirmed cannabis abstinence.
Time frame: The Groton Maze Learning Task will be administered before and after the 4 week abstinence period.
To determine the relationship between hippocampal [11C]APP311 (UCB-J) binding and performance on the Groton Maze Learning task, a cognitive task that measures total number of errors, in CUDs before and after 4 weeks of confirmed cannabis abstinence.
Time frame: Before and after the 4 week abstinence period.
To determine the relationship between hippocampal synaptic density (n=26+12 historical data) and indices of cannabis exposure such as first age of cannabis exposure, as measured by self-report data.
Time frame: Before and after the 4 week abstinence period.
To determine the relationship between hippocampal synaptic density (n=26+12 historical data) and indices of cannabis exposure such as cumulative lifetime cannabis exposure, as measured by self-report data.
Time frame: Approximately 8 CUD participants will be asked to return for a third [11C]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan. (8 weeks in total).
To explore whether hippocampal synaptic density and function continues to improve with 8 weeks of abstinence in a subset of CUD participants using [11C]APP311 (UCB-J).
Contact information is provided by the study sponsor or research team.
Yale University
Other
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