Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT05472818

SV2A Density Cannabis Use Disorder

Led by Yale University · Updated on 2026-03-12

51

Participants Needed

1

Research Sites

524 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The main purpose of this study is to determine whether hippocampal synaptic vesicle density estimated by hippocampal \[11C\]APP-311/\[11C\]UCB-J binding in individuals diagnosed with cannabis use disorder (CUDs) improves with at least 4 weeks of confirmed abstinence from cannabis, in comparison to healthy controls (HCs). Furthermore, any change in synaptic vesicle density will be placed in functional context by measuring verbal memory, which is sensitive to hippocampal function, before and after at least 4 weeks of confirmed abstinence. Finally, the relationship between hippocampal \[11C\]UCB-J binding in CUDs with measures of cannabis exposure (e.g., age of initiation, cumulative lifetime dose) will be explored.

CONDITIONS

Official Title

SV2A Density Cannabis Use Disorder

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent
  • Male and female aged 18 to 75 years
  • Daily cannabis use (for CUD participants)
  • Positive urine screen for cannabinoids and negative for other drugs (for CUD participants)
  • Diagnosis of DSM-5 cannabis use disorder with at least moderate severity (4 or more symptoms) (for CUD participants)
  • Willingness to set a date to attempt to quit cannabis use (for CUD participants)
  • Physically healthy with no unstable medical conditions
  • For women of childbearing potential and men, willingness to use birth control and inform staff immediately if pregnancy occurs
  • Willing and able to provide informed consent (for healthy controls)
  • BMI between 19 and 35 kg/m2 (for healthy controls)
  • Good health based on medical history, physical exam, ECG, and lab tests (for healthy controls)
  • Negative urine drug screen (for healthy controls)
  • If female, not pregnant or breastfeeding (for healthy controls)
  • Use of acceptable birth control method if female of childbearing potential (for healthy controls)
  • Able to read, write, communicate effectively, and comply with study requirements (for healthy controls)
  • Have arterial access for blood sampling as needed (for healthy controls)
Not Eligible

You will not qualify if you...

  • Clinically significant lab abnormalities or positive urine drug screen for drugs other than cannabinoids (for CUD participants)
  • Pregnancy or lactation in women
  • Implanted or embedded metal objects or fragments that pose risk during MRI
  • History of working with ferrous metals that may cause unknown metal fragments
  • Recent exposure to ionizing radiation exceeding recommended limits
  • History of bleeding disorders or current use of anticoagulants
  • Blood donation within 8 weeks prior to study
  • Use of medications that may alter synaptic density
  • History or presence of unstable or significant medical conditions including respiratory, gastrointestinal, renal, hepatic, pancreatic, hematological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological disorders, or cancer (for healthy controls)
  • MRI contraindications such as pacemakers, artificial joints, non-removable piercings, or claustrophobia (for healthy controls)
  • Participation in research involving ionizing radiation within one year that exceeds dose limits (for healthy controls)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Yale University School of Medicine

New Haven, Connecticut, United States, 06511

Actively Recruiting

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Research Team

S

Shannon Zeilman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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