SV2A in Older Adults

Effect of Cannabis Use on Synaptic Density in Older Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Cannabis Use
• Intervention / Treatment: Drug: [11C]UCB-J PET

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Angerlyk Frytz, MD; Phone Number: 203-974-7822; Email: angerlyk.frytz@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Conneticut Mental Health Center
      • Contact: Angerlyk Frytz, MD; Phone Number: 203-974-7822; Email: angerlyk.frytz@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hippocampal synaptic density	Measure of synaptic density in the hippocampus	1 month

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Deepak C D'Souza, MBBS, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: July 16, 2022
• First Submitted That Met QC Criteria: July 16, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Marijuana Abuse
• Other Study ID Numbers: 2000032183; 1R21DA054491-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No