SV2A Density Cannabis Use Disorder

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05472818
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Cannabis Use Disorder
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • [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.

Study Details

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.

Key Dates

Start date
Apr 12, 2022
Status verified
Mar 2026
Primary completion
May 30, 2027
Completion
May 31, 2032

Study Design

Enrollment
51 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: CUD Group
    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.
  • Active Comparator: Healthy Controls
    Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart.

Primary Outcome Measure

Hippocampal SV2A synaptic density [ Time Frame: All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06511-

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Yale University School of Medicine· New Haven, CT

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