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SV2A in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05465538
Recruitment Status : Recruiting
First Posted : July 19, 2022
Last Update Posted : August 18, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Rajiv Radhakrishnan, Yale University

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.

Condition or disease Intervention/treatment Phase
Cannabis Use Drug: [11C]UCB-J PET Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Cannabis Use on Synaptic Density in Older Adults
Actual Study Start Date : July 6, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Cannabis using older adults
Subjects undergo a single PET scan using [11C]UCB-J
Drug: [11C]UCB-J PET
Single PET scan using the radioligand [11C]UCB-J

Healthy controls
Subjects undergo a single PET scan using [11C]UCB-J
Drug: [11C]UCB-J PET
Single PET scan using the radioligand [11C]UCB-J




Primary Outcome Measures :
  1. Hippocampal synaptic density [ Time Frame: 1 month ]
    Measure of synaptic density in the hippocampus



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05465538


Contacts
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Contact: Rajiv Radhakrishnan, MBBS, MD 203-932-5711 ext 3390 rajiv.radhakrishnan@yale.edu

Locations
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United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Kayla G Cottiers, BS    203-974-7544    kayla.cottiers@yale.edu   
Contact: Kimberlee Forselius-Bielen    203-974-7540    kimberlee.forselius@yale.edu   
Principal Investigator: Rajiv Radhakrishnan, MD         
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Rajiv Radhakrishnan, MBBS, MD Yale University
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Responsible Party: Rajiv Radhakrishnan, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT05465538    
Other Study ID Numbers: 2000032183
1R21DA054491-01 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders