SV2A in Older Adults

Cannabis Use Clinical Trial

Official title:

Effect of Cannabis Use on Synaptic Density in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05465538
• Other study ID #: 2000032183
• Secondary ID: 1R21DA054491-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 6, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Yale University
• Contact: Rajiv Radhakrishnan, MBBS, MD
• Phone: 203-932-5711
• Email: rajiv.radhakrishnan[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse

Intervention

Drug:
• [11C]UCB-J PET
Single PET scan using the radioligand [11C]UCB-J

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hippocampal synaptic density	Measure of synaptic density in the hippocampus	1 month