NCT05465538

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
17mo left

Started Jul 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jul 2022Sep 2027

Study Start

First participant enrolled

July 6, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

July 16, 2022

Last Update Submit

February 26, 2026

Conditions

Cannabis Use

Outcome Measures

Primary Outcomes (1)

  • Hippocampal synaptic density

    Measure of synaptic density in the hippocampus

    1 month

Study Arms (2)

Cannabis using older adults

OTHER

Subjects undergo a single PET scan using \[11C\]UCB-J

Drug: [11C]UCB-J PET

Healthy controls

OTHER

Subjects undergo a single PET scan using \[11C\]UCB-J

Drug: [11C]UCB-J PET

Interventions

[11C]UCB-J PETDRUG

Single PET scan using the radioligand \[11C\]UCB-J

Cannabis using older adultsHealthy controls

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Conneticut Mental Health Center

New Haven, Connecticut, 06519, United States

RECRUITING

Study Officials

  • Deepak C D'Souza, MBBS, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angerlyk Frytz, MD

CONTACT

203-974-7822angerlyk.frytz@yale.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2022

First Posted

July 19, 2022

Study Start

July 6, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)