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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA054314 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CUD Group | Active Comparator | Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart. CUD participants will be asked to abstain from cannabis for the 4 week period. |
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| Healthy Controls | Active Comparator | Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [11C]APP311 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hippocampal SV2A synaptic density | Hippocampal SV2A synaptic density will be measured using [11C]APP311 (UCB-J). | All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Hippocampal binding and Hippocampal Verbal Memory Task | 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. | The Auditory Verbal Learning Task (AVLT) will be administered before and after the 4 week abstinence period. |
| Measure | Description | Time Frame |
|---|---|---|
| Hippocampal synaptic density and first age of cannabis exposure | 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. | Before and after the 4 week abstinence period. |
| Hippocampal synaptic density and cumulative lifetime cannabis exposure. |
CUD Participants Inclusion Criteria:
CUD Participants Exclusion Criteria:
Healthy Controls Inclusion Criteria:
Healthy Controls Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shannon Zeilman | Contact | 203-974-7822 | shannon.zeilman@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Deepak C D'Souza | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | Recruiting | New Haven | Connecticut | 06511 | United States |
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In this study, patients with cannabis use disorder (CUD) and matched healthy controls will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart. CUD participants will be asked to abstain from cannabis for the 4 week period. A small subset of CUD participants will be asked to continue abstaining for an additional approx. 4 weeks to complete one additional scan. Participants may also complete a neurocognitive battery, various psychiatric evaluations, a physical examination, an ECG, blood tests, and questionnaires. CUD participants will complete bi-weekly study visits to confirm abstinence.
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| Hippocampal binding and Groton Maze Learning in CUDs | 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. | The Groton Maze Learning Task will be administered 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. |
| Before and after the 4 week abstinence period. |
| Hippocampal SV2A synaptic density after 8 weeks | 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). | 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). |