Back to resultsSV2A in Older Adults
Primary Purpose
Cannabis Use
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[11C]UCB-J PET
Sponsored by
About this trial
This is an interventional other trial for Cannabis Use
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent
- Male or female, aged ≥50 years
- No history of significant medical or neurological disease
- If woman of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study and up to one month after completion of PET scans
Exclusion Criteria:
- Women with a positive pregnancy test or women who are lactating
- Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits;
- History of a bleeding disorder or are currently taking anticoagulants
- Subjects who have donated blood within 8 weeks of the present study
Sites / Locations
- Connecticut Mental Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Cannabis using older adults
Healthy controls
Arm Description
Subjects undergo a single PET scan using [11C]UCB-J
Subjects undergo a single PET scan using [11C]UCB-J
Outcomes
Primary Outcome Measures
Hippocampal synaptic density
Measure of synaptic density in the hippocampus
Secondary Outcome Measures
Full Information
NCT ID
NCT05465538
First Posted
July 16, 2022
Last Updated
September 7, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05465538
Brief Title
SV2A in Older Adults
Official Title
Effect of Cannabis Use on Synaptic Density in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to examine the effect of cannabis use on brain synaptic density among older adults using [11C]UCB-J PET imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cannabis using older adults
Arm Type
Other
Arm Description
Subjects undergo a single PET scan using [11C]UCB-J
Arm Title
Healthy controls
Arm Type
Other
Arm Description
Subjects undergo a single PET scan using [11C]UCB-J
Intervention Type
Drug
Intervention Name(s)
[11C]UCB-J PET
Intervention Description
Single PET scan using the radioligand [11C]UCB-J
Primary Outcome Measure Information:
Title
Hippocampal synaptic density
Description
Measure of synaptic density in the hippocampus
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Able to provide informed consent
Male or female, aged ≥50 years
No history of significant medical or neurological disease
BMI ≤ 50
If woman of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study and up to one month after completion of PET scans
Exclusion Criteria:
Women with a positive pregnancy test or women who are lactating
Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits;
History of a bleeding disorder or are currently taking anticoagulants
Subjects who have donated blood within 8 weeks of the present study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rajiv Radhakrishnan, MBBS, MD
Phone
203-932-5711
Ext
3390
Email
rajiv.radhakrishnan@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajiv Radhakrishnan, MBBS, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayla G Cottiers
Phone
203-974-7544
Email
kayla.cottiers@yale.edu
First Name & Middle Initial & Last Name & Degree
Kimberlee Forselius-Bielen
Phone
203-974-7540
Email
kimberlee.forselius@yale.edu
First Name & Middle Initial & Last Name & Degree
Rajiv Radhakrishnan, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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SV2A in Older Adults
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