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TerminatedEarly phase 1

Understanding Effects of Cannabis Use and Abstinence on Neural Glutamate Homeostasis

Key facts

Who runs it
Yale University
Where
New Haven, United StatesSee the site
Trial code
Status
Terminated
Phase
Early phase 1
People taking part
6 people enrolled
Started
1 Mar 2023
Ended
3 Jul 2024
Type of study
Interventional, 2 groups
Treatments tested
  • [18F]FPEB with PET
  • Cannabis abstinence
Record updated
19 August 2025
Why it stopped
Insufficient funding

Who can take part

Age
18 years to 55 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • HC and CUD Group:
  • Voluntary, written, informed consent
  • Physically healthy by medical history, physical, neurological, ECG and laboratory exams
  • No personal or first-degree relative history of psychiatric disorders (outside of cannabis use for CUD group)
  • Full scale and verbal IQs > 80 (Wechsler Adult Intelligence Scale, Fourth Edition; WAIS-IV); CUD group:
  • Cannabis use disorder as determined by DSM-5 structured interviews
  • Urine toxicology evidence of cannabinoid use; HC group:
  • lifetime cannabis exposure less than 20 times
  • no cannabis use in the past 2 years by self-report
  • a negative urine drug screen

Who cannot take part

  • Urine toxicology results positive for other drugs such as opiates / opiate metabolites (e.g., methadone, buprenorphine, etc.)
  • Current use of psychotropic and/or potentially psychoactive prescription medications
  • Medical contraindications to MRI imaging (e.g., ferromagnetic implants/foreign bodies, claustrophobia, etc.)
  • Other substance use disorder within 1 year, except for nicotine
  • Another primary DSM-5 Axis I major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) per SCID-5
  • A history of significant medical (cardiac, infectious, metabolic) or neurological illness (e.g., cerebrovascular disease, traumatic brain injury)
  • A history of seizures/epilepsy
  • Subjects will be excluded for major medical or neurological illness or laboratories consistent with these illnesses or suggesting contraindication to PET or MR imaging
  • Pregnancy or breastfeeding (women)

Where in United States

  • The Anlyan CenterNew Haven, United States

About the trial

What the trial wants to find out

This study will be the first in vivo human multimodal neuroimaging study exploring the relationship between mGluR5 availability (PET), neural oscillations (EEG), and cognitive function in people with CUD. The goal is to test the overall hypothesis that mGluR5 availability is higher in people with CUD compared with HC. In Aim 1, the investigators will determine differences in mGluR5 availability between people with CUD and HC in the fronto-limbic brain circuit. Aim 2 examines the associations between mGluR5 availability, CUD severity, neural oscillations, and cognitive function in CUD subjects. Aim 3 will determine how prolonged abstinence from chronic cannabis use affects mGluR5 availability, neural oscillations, and cognitive function in CUD subjects.

The 2 groups in the trial

  • Cannabis use disorderTreatment being tested

    CUD participants participants undergo neuroimaging, cognitive testing, and EEG at baseline and following cannabis abstinence at 4 weeks follow-up. Participants will receive motivational enhancement and contingency management during the 4-week abstinence period.

    Treatment: [18F]FPEB with PET and Cannabis abstinence

  • Healthy controlTreatment being tested

    Healthy control participants undergo neuroimaging, cognitive testing, and EEG at baseline.

    Treatment: [18F]FPEB with PET

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
19 August 2025